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Natrelle Inspira Cohesive Breast Implants
FDA UDIClass III (US FDA UDI)
by Allergan
Identity
- Trade Name
- Natrelle Inspira Cohesive Breast Implants FDA UDI
- Generic Name
- Silicone gel-filled breast implant, textured-surface FDA UDI
- Device Name
- Natrelle Inspira TCL 320cc Low profile BIOCELL |textured|round|silicone FDA UDI
- Model / Reference
- TCL-320 FDA UDI
- Description
- Natrelle Inspira TCL 320cc Low profile BIOCELL |textured|round|silicone FDA UDI
Identifiers
- Catalog Number
- TCL-320 FDA UDI
- Primary DI / UDI-DI
- 10888628030510 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 Cohesive Breast Implants 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 f9aee0a0-d9b1-4d50-a4b8-3bb194e76683 38 fields · synced May 31, 2026