AccessGUDID - DEVICE: ComPel Single Wrap (00634916080018)

GUDID

Device Identifier (DI) Information

Brand Name: ComPel Single Wrap
Version or Model: 276665L1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 276665L1
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916080018
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2024
Device Count: 36
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: COMPEL SINGLE WRAP 45X45 KAUM - RM(98 7647)2-KAUM'USE:27666502

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
40517	Sterilization packaging, reusable	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923408	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

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: ac26e950-11a6-492d-8d0c-bfa539736b67
Public Version Date: December 27, 2024
Public Version Number: 5
DI Record Publish Date: January 29, 2018