AccessGUDID - DEVICE: MediChoice (10885632436741)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: 58276
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632436741
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Rigid Container Sterilization 15.5x9.5x0.25 Silicone Blue CA/1 Not made with Natural Rubber Latex Medichoice

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):	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?
63376	Sterilization container mat	A non-sterile soft polymer sheet intended to be placed within a container/tray used for instrument sterilization, to protect and help facilitate complete sterilization of the underside of instruments. It is in the form of a textured sheet, typically with flexible polymer pins designed to reduce instrument/surface contact. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	TRAY, SURGICAL, INSTRUMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131407	000
K233578	000

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: 2cb1d49c-f1d8-4964-99b2-1480812cb86d
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025