AccessGUDID - DEVICE: CARDINAL HEALTH (10195594373436)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: SNEW1CRH11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SNEW1CRH11
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10195594373436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: HFHS CRANIOTOMY PACK I

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
56302	Craniotomy kit	A collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJG	Neurological tray

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 182722d7-ffbe-4759-ba2d-7eb31f2e544a
Public Version Date: October 15, 2021
Public Version Number: 1
DI Record Publish Date: October 07, 2021