AccessGUDID - DEVICE: CARDINAL HEALTH (10885380082818)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: CH10-0040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CH10-0040
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380082818
Issuing Agency: GS1
Commercial Distribution End Date: June 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Bending Template 7 Holes For 3.5mm Limited Contact & Dynamic Compression and Locking Plates

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?
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: c9f8f8bf-979b-46d3-990f-4d6bc2c98d22
Public Version Date: July 23, 2018
Public Version Number: 2
DI Record Publish Date: June 05, 2018