Identity
- Trade Name
- Coaptite FDA UDI
- Generic Name
- Dermal tissue reconstructive material, synthetic mineral FDA UDI
- Device Name
- The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles. FDA UDI
- Model / Reference
- 8005P10 FDA UDI
- Description
- The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles. FDA UDI
Identifiers
- Catalog Number
- M0068903000 FDA UDI
- Primary DI / UDI-DI
- 08714729804796 FDA UDI
- PMA Number
- P040047 FDA UDI
- FDA Product Code
- LNM FDA UDI
- GMDN Term
- Dermal tissue reconstructive material, synthetic mineral FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Dermal tissue reconstructive material, synthetic mineral
Coaptite by Merz North America, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermal tissue reconstructive material, synthetic mineral.
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- Sculptra — GALDERMA LABORATORIES, L.P. · Class III
- Sculptra — GALDERMA LABORATORIES, L.P. · Class III
- Sculptra — GALDERMA LABORATORIES, L.P. · Class III
- Sculptra — Qmed, Inc. · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Merz North America, Inc.
Sources (1)
- FDA UDI efacdaf4-c15e-4ada-a4f7-fef4c982c72d 38 fields · synced Jun 9, 2026