FDA UDI
In Commercial Distribution
🇺🇸 United States
SIENTRA Silicone Gel Breast Implant Sizer
DI: 00810076890517
·
Model: GS10712-440MP
·
Sientra, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SIENTRA Silicone Gel Breast Implant Sizer
- Primary DI
- 00810076890517
- Version / Model
- GS10712-440MP
- Catalog Number
- GS10712-440MP
- Company Name
- Sientra, Inc.
- Labeler DUNS
- 010209877
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 2
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- 1fae8d05-ca69-4ad2-bf64-e68f8ebe0c78
Device Description
Silicone Gel Sizer, Smooth Round, Moderate Projection, 440 cc
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 |
|---|---|---|---|---|
| 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 | 00810076890517 | GS1 |
Customer Contacts
- Phone
- 888-708-0808
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200706 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Volume:440 cc |