FDA UDI
In Commercial Distribution
🇺🇸 United States
Puregraft Serene Breast Implant
DI: 00850034511788
·
Model: 515CC
·
Bimini Technologies LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Puregraft Serene Breast Implant
- Primary DI
- 00850034511788
- Version / Model
- 515CC
- Company Name
- Bimini Technologies LLC
- Labeler DUNS
- 076649467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-28
- Public Version
- 1
- Public Version Date
- 2024-04-05
- Public Version Status
- New
- Public Device Record Key
- d9a2a042-9770-48a3-b6f4-ad8df737f1ab
Device Description
Saline Breast Implant
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | General, Plastic Surgery | 878.3530 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63551 | Saline-filled breast implant, internally-structured | A sterile implantable device designed to reconstruct or augment the breast that is composed of a smooth silicone outer shell containing a nested silicone-shell support structure, creating multiple nested lumens inflated with sterile isotonic saline to the desired size. Movement of saline between the lumens is possible through slits and tempered by baffles; the implant has separate fill valves for each lumen and is typically filled with saline before or during the implant procedure. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850034511801 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00850034511788 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120011 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 515 | Milliliter |