Aegis Lifesciences · 89-08 · INDIA
For Aegis Lifesciences, import alert is 89-08; country is INDIA; 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 Agent Aborbable Hemostatic Collagen Blend; product code is 79 L - - MF Agent, Absorbable Hemostatic, Collagen Based; date published is 03/10/2014; address is 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA, verified against its source on 2026-09-30.
- Firm
- Aegis Lifesciences 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
- INDIA verified
- Address
- 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA verified
- Date published
- 03/10/2014 verified
- Product code
- 79 L - - MF Agent, Absorbable Hemostatic, Collagen Based verified
- Product
- Agent Aborbable Hemostatic Collagen Blend verified
- FDA notes
- Class III verified
What the source says
Aegis Lifesciences Date Published : 03/10/2014 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA
— accessdata.fda.gov, retrieved 2026-09-15
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
79 L - - MF Agent, Absorbable Hemostatic, Collagen Based Date Published: 03/10/2014 Desc: Agent Aborbable Hemostatic Collagen Blend Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html