AccessGUDID - DEVICE: CARDINAL HEALTH (10885380090691)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: K20TP150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K20TP150
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380090691
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: 2.0mm Guide Wire with Trocar Point 150mm

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?
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). 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: fe116dc0-7d19-4bde-b43e-b83c863d2823
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: June 06, 2018