FDA UDI
In Commercial Distribution
🇺🇸 United States
MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer
DI: 00081317002604
·
Model: 351-125SZ
·
MENTOR TEXAS L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MENTOR Round Moderate Profile Single Use Saline Breast Implant Sizer
- Primary DI
- 00081317002604
- Version / Model
- 351-125SZ
- Catalog Number
- 351-125SZ
- Company Name
- MENTOR TEXAS L.P.
- Labeler DUNS
- 167450993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-16
- Public Version
- 5
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- a8be71e5-f035-46e5-b145-36d8ea40ed7c
Device Description
Round Moderate Profile Saline Breast Implant Sizer, 125cc
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 |
|---|---|---|---|---|
| MRD | SIZER, MAMMARY, BREAST IMPLANT VOLUME | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34178 | Invasive breast implant sizer, fixed, single-use | A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00081317002604 | GS1 |
Customer Contacts
- Phone
- +1(800)235-5731
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010709 | 000 |