AccessGUDID - DEVICE: 4TR (00852714003248)

GUDID

Device Identifier (DI) Information

Brand Name: 4TR
Version or Model: AUXP-4TR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nuo Therapeutics, Inc.

Primary DI Number: 00852714003248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118447207 *Terms of Use

Device Description: Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit

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):	Yes
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?
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMQ	Peripheral Blood Processing Device For Wound Management

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK060007	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 144af523-0f43-4c60-ae46-9ba663bdfe8a
Public Version Date: March 29, 2024
Public Version Number: 1
DI Record Publish Date: March 21, 2024