AccessGUDID - DEVICE: CUSTOM (03613720223320)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOM
Version or Model: A99140100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICREA INTERNATIONAL

Primary DI Number: 03613720223320
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 383228632 *Terms of Use

Device Description: NUTDRIVER WITH VISUAL CHECKS

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):	Yes
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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXC	Wrench

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 5d308783-0f44-45bc-89f3-4ca472101392
Public Version Date: December 16, 2022
Public Version Number: 5
DI Record Publish Date: January 31, 2017