Model: 1
DI: 08681877009857
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fde9a7b0-8b82-419b-bab5-eaf21f5667b1
Distribution Status:
In Commercial Distribution
DUNS Number:
595779748
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08681877009857
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56627
Name: Autologous adipose tissue noninvasive processing set
Definition:
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.
FDA Product Codes
None