FDA UDI
In Commercial Distribution
🇺🇸 United States
MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems
DI: 00081317004059
·
Model: 350-DOMPK
·
MENTOR TEXAS L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems
- Primary DI
- 00081317004059
- Version / Model
- 350-DOMPK
- Catalog Number
- 350-DOMPK
- Company Name
- MENTOR TEXAS L.P.
- Labeler DUNS
- 167450993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 5
- Public Version Date
- 2021-02-11
- Public Version Status
- Update
- Public Device Record Key
- 7aaa39f3-2abd-4d32-b1d6-62554f58d909
Device Description
Dome Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FWM | Prosthesis, breast, inflatable, internal, saline | General, Plastic Surgery | 878.3530 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64083 | Saline-filled breast implant, unstructured, smooth-surface | An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device 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 | 00081317004059 | GS1 |
Customer Contacts
- Phone
- +1(800)235-5731
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990075 | 019 |