AccessGUDID - DEVICE: MECRON Wrist Guard L: 23 cm, U: 19-22 cm (00609271950863)

GUDID

Device Identifier (DI) Information

Brand Name: MECRON Wrist Guard L: 23 cm, U: 19-22 cm
Version or Model: OS233204
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS233204
Company Name: Darco (Europe) GmbH

Primary DI Number: 00609271950863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343551081 *Terms of Use

Device Description: L Black left

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?
41459	Wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILH	SPLINT, HAND, AND COMPONENTS

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: 08f9bd70-7bbc-4027-b5cc-fa3a858476b2
Public Version Date: January 27, 2025
Public Version Number: 2
DI Record Publish Date: February 08, 2023