AccessGUDID - DEVICE: Medichoice (10885632431371)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: 55752
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632431371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Clipper White POM White CA/60 Replaces 88100 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":	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?
47402	Umbilical cord clamp/cutter	A sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDJ	SCISSORS, UMBILICAL

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: 7786460c-dcc2-4935-8b49-14cf6d01302c
Public Version Date: December 02, 2024
Public Version Number: 1
DI Record Publish Date: November 22, 2024