AccessGUDID - DEVICE: CARDINAL HEALTH (10888439704228)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: SOPCGASAC1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SOPCGASAC1
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10888439704228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: OP SC SHOULDER ARTHRO PK CMC

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?
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJH	Orthopedic 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9452478a-e38c-46bd-8194-4d9a8c862883
Public Version Date: February 10, 2020
Public Version Number: 1
DI Record Publish Date: January 31, 2020