AccessGUDID - DEVICE: Disposable Tattoo Arm Sleeve Cover Barrier (00616784213729)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Tattoo Arm Sleeve Cover Barrier
Version or Model: 2137
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784213729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal

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":	Yes
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?
43222	Limb-worn device hygienic cover	A device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXP	Cover, Shoe, Operating-Room

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 8e020a52-c256-4eb2-84f8-f8dab200de36
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: June 21, 2021