AccessGUDID - DEVICE: CARDINAL HEALTH (10885380126024)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: CH003-100N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CH003-100N
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380126024
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2018
Device Count: 2
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Cardinal Health Navigation Pins Stainless Steel

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:	Yes
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?
62546	Intraoperative orthopaedic bone pin/screw, single-use	A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131264	000

Device Exempt from Premarket Submission: No 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
Width: 3 Millimeter
Length: 100 Millimeter

Device Record Status

Public Device Record Key: c6d93d8e-b9f1-4cd7-b9ca-e430167058d1
Public Version Date: June 02, 2023
Public Version Number: 4
DI Record Publish Date: June 08, 2018