AccessGUDID - DEVICE: Puregraft (00863445000314)

GUDID

Device Identifier (DI) Information

Brand Name: Puregraft
Version or Model: 850
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 850/PURE
Company Name: PUREGRAFT LLC

Primary DI Number: 00863445000314
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 079508934 *Terms of Use

Device Description: Puregraft 850 System

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):	No
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 collection/washing set	A collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUU	System, Suction, Lipoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113255	000

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: c458d7d4-848d-400b-824f-5aab56aa767d
Public Version Date: May 25, 2023
Public Version Number: 4
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10863445000311	5	00863445000314	2023-05-24	Not in Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 858-348-8050
Email: info@puregraft.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES