AccessGUDID - DEVICE: Puregraft 850 System Twin Pack (00850034511023)

GUDID

Device Identifier (DI) Information

Brand Name: Puregraft 850 System Twin Pack
Version or Model: 850/TWIN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bimini Technologies LLC

Primary DI Number: 00850034511023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076649467 *Terms of Use

Device Description: A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient. Two bags included per packaging unit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56627	Autologous adipose tissue noninvasive processing set	A noninvasive collection of non-powered devices designed as a closed system for the collection and processing (e.g., filtering, washing) of autologous fat tissue for reinjection into the patient from whom it was taken (autologous lipotransfer) for aesthetic body contouring. It consists of containers (typically filtration and waste collection bags) and connection accessories (e.g., connectors, tubing); it does not include invasive needles/cannulae. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK220693	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6bcd555a-46c0-4348-8b49-6d34fce72a7a
Public Version Date: July 21, 2025
Public Version Number: 2
DI Record Publish Date: August 22, 2024