Damiva Inc · 89-08 · CANADA
For Damiva Inc, import alert is 89-08; country is CANADA; 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html