FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Natrelle Inspira Cohesive Breast Implants
DI: 10888628030718
·
Model: TCLP-340
·
Allergan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Natrelle Inspira Cohesive Breast Implants
- Primary DI
- 10888628030718
- Version / Model
- TCLP-340
- Catalog Number
- TCLP-340
- Company Name
- Allergan, Inc.
- Labeler DUNS
- 144796497
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 4
- Public Version Date
- 2021-10-14
- Public Version Status
- Update
- Public Device Record Key
- 9737e31b-2a02-4b3a-8b6d-b71858dda6c9
- Distribution End Date
- 2019-07-24
Device Description
Natrelle Inspira TCLP 340cc Low plus profile BIOCELL |textured|round|silicone
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | General, Plastic Surgery | 878.3540 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64082 | Silicone gel-filled breast implant, textured-surface | An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888628030718 | GS1 |
Customer Contacts
- Phone
- 8006244261
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P020056 | 034 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 340 cc |