MENTOR MemoryGel Breast Implant
- Primary DI
- 00081317001089
- Brand
- MENTOR MemoryGel Breast Implant
- Company
- MENTOR TEXAS L.P.
- Model
- 3544400
- Catalog number
- 3544400
- Device description
- SILTEX Round High Profile Gel-Filled Breast Implant, 400cc
- Published
- 2014-09-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
xx.xxProduct Codes
| Code | Name |
|---|---|
| FTR | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | General, Plastic Surgery | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00081317001089 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00081317001089 | 00081317001089 | 081317001089 | 0081317001089 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)235-5731 | xx@xx.xx |
Regulatory Flags
- DUNS number
- 167450993
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 10081317032691 | MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile | SZUHE1135 | SZ-UHE-1135 | 2025-04-01 |
| 10081317032707 | MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile | SZUHE1240 | SZ-UHE-1240 | 2025-04-01 |
| 10081317032714 | MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile | SZUHE1340 | SZ-UHE-1340 | 2025-04-01 |
| 10081317032721 | MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile | SZUHE1445 | SZ-UHE-1445 | 2025-04-01 |
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| 10081317028700 | MENTOR Smooth Round Moderate Plus Profile | 3502300D | 350-2300D | 2025-03-17 |
| 10081317028717 | MENTOR Smooth Round Moderate Plus Profile | 3502325D | 350-2325D | 2025-03-17 |
| 10081317028724 | MENTOR Smooth Round Moderate Plus Profile | 3502350D | 350-2350D | 2025-03-17 |
| 10081317028731 | MENTOR Smooth Round Moderate Plus Profile | 3502375D | 350-2375D | 2025-03-17 |
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