FDA UDI
In Commercial Distribution
🇺🇸 United States
Combined Adapter
DI: 00850034511016
·
Model: ADAPT/PURE
·
Bimini Technologies LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Combined Adapter
- Primary DI
- 00850034511016
- Version / Model
- ADAPT/PURE
- Company Name
- Bimini Technologies LLC
- Labeler DUNS
- 076649467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-09
- Public Version
- 1
- Public Version Date
- 2022-02-17
- Public Version Status
- New
- Public Device Record Key
- cbca0b1e-3ea7-44ca-9e38-cd9ac7baafac
Device Description
The Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56638 | Collection syringe adaptor, reusable | A small device designed be placed over the top of a syringe to encase the tip of the syringe as means to modify the shape and the size of the syringe tip. It is typically made of stainless steel or a durable polymer material and its shape and size mimics that of the appropriately-matched syringe barrel (i.e., 60 cc, 30 cc, 10 cc versions of a Toomey style syringe). It is typically used for the transfer of human tissue or other substances from one container to another during plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850034511016 | GS1 |