Micromed Srl · 89-08 · ITALY
For Micromed Srl · 89-08 · ITALY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is ITALY; product is Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | Intraocular Silicone Oil | GasMate; product code is 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular; date published is 09/29/2009; address is Via Oberdan 21 , Fonte Nuova, Rome ITALY, verified against its source on 2026-09-16.
- Firm
- Micromed Srl verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- ITALY verified
- Address
- Via Oberdan 21 , Fonte Nuova, Rome ITALY verified
- Date published
- 09/29/2009 verified
- Product code
- 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular each item verified
- Product
- Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | Intraocular Silicone Oil | GasMate each item verified
- FDA notes
- Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 each item verified
What the source says
Micromed Srl Date Published : 09/29/2009 Via Oberdan 21 , Fonte Nuova, Rome ITALY 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009
— accessdata.fda.gov, retrieved 2026-09-15
The same source also states
Micromed Srl Date Published : 01/23/2019 Vle Valpadana 126 , Romaroma, ITALY 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html