Identity
- Trade Name
- Natrelle INSPIRA FDA UDI
- Generic Name
- Silicone gel-filled breast implant, textured-surface FDA UDI
- Device Name
- NATRELLE INSPIRA Sty TRF-770 Full profile BIOCELL |textured|round|silicone FDA UDI
- Model / Reference
- TRF-770 FDA UDI
- Description
- NATRELLE INSPIRA Sty TRF-770 Full profile BIOCELL |textured|round|silicone FDA UDI
Identifiers
- Catalog Number
- TRF-770 FDA UDI
- Primary DI / UDI-DI
- 10888628008427 FDA UDI
- PMA Number
- P020056 FDA UDI
- FDA Product Code
- FTR FDA UDI
- GMDN Term
- Silicone gel-filled breast implant, textured-surface FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.3540 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Natrelle INSPIRA by Allergan — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P020056 also covers:
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- NATRELLE Silicone-Filled Breast Implants — Allergan
- Natrelle INSPIRA Breast Implants — Allergan
- Natrelle INSPIRA Breast Implants — Allergan
- Natrelle INSPIRA Breast Implants — Allergan
- Natrelle INSPIRA Breast Implants — Allergan
- Natrelle Inspira Cohesive Breast Implants — Allergan
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
- Allergan
Sources (1)
- FDA UDI 4d3a1515-13e6-4982-896d-e9575ea1779e 38 fields · synced Jun 1, 2026