Damiva Inc · 89-08 · CANADA
For Damiva Inc · 89-08 · CANADA, 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 CANADA; product is Mae Vaginal Suppository | Mae Vaginal Suppository; product code is 62 M - - 99 Anti-Pruritic N.E.C. | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible; date published is 12/13/2017; address is 639 Dupont St Unit 228 , Toronto, Ontario CANADA, verified against its source on 2026-09-16.
- Firm
- Damiva Inc 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
- CANADA verified
- Address
- 639 Dupont St Unit 228 , Toronto, Ontario CANADA verified
- Date published
- 12/13/2017 verified
- Product code
- 62 M - - 99 Anti-Pruritic N.E.C. | 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible each item verified
- Product
- Mae Vaginal Suppository | Mae Vaginal Suppository each item verified
- FDA notes
- Class II device without a valid 510K | Class II device without a valid 510K each item verified
What the source says
Damiva Inc Date Published : 12/13/2017 639 Dupont St Unit 228 , Toronto, Ontario CANADA 62 M - - 99 Anti-Pruritic N.E.C. Date Published: 12/13/2017 Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K 85 N - - UC Lubricant, Patient, Vaginal, Latex Compatible Date Published: 12/13/2017 Desc: Mae Vaginal Suppository Notes: Class II device without a valid 510K
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.