FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoPose Access
DI: 00850034511320
·
Model: ABS-101024-1
·
Bimini Technologies LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoPose Access
- Primary DI
- 00850034511320
- Version / Model
- ABS-101024-1
- 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
- 50c6c49a-43dd-45c8-90e3-3bead3c864dc
Device Description
A pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.
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
- 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 |
|---|---|---|---|---|
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63583 | Resective skin contouring/liposuction system depth guide | A sterile component of a resective skin contouring/liposuction system intended to connect the system handpiece to a single coring needle to function as a guide for the insertion depth of the needle. It is one of a set, or a set, of graduated sizes and provides a sideport for connection to the suction generator for fat aspiration during insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850034511320 | GS1 |