AccessGUDID - DEVICE: Critical Cover (10817583023053)

GUDID

Device Identifier (DI) Information

Brand Name: Critical Cover
Version or Model: MS-01J06-8TH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MS-01J06-8TH
Company Name: Alpha Pro Tech, Inc.

Primary DI Number: 10817583023053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 102710720 *Terms of Use

Device Description: Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV

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?
61939	Surgical sleeve cover	A forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

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: 10ef6dfb-96b0-4930-89f1-1289a58c4619
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: December 18, 2020