Micromed Srl · 89-08 · ITALY
For Micromed Srl, import alert is 89-08; country is ITALY; 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)"; product is Intraocular Silicone Oil | Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | 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 listed twice: 09/29/2009 and 01/23/2019; address is listed twice: Via Oberdan 21 , Fonte Nuova, Rome ITALY and Vle Valpadana 126 , Romaroma, ITALY, verified against its source on 2026-09-30.
- 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
- Vle Valpadana 126 , Romaroma, ITALY also listed
- Date published
- 09/29/2009 verified
- 01/23/2019 also listed
- 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
- Intraocular Silicone Oil | Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | 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
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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: 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 - - 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-22
The same source also states
Micromed Srl Date Published : 01/23/2019 Vle Valpadana 126 , Romaroma, ITALY
— accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html