AccessGUDID - DEVICE: NA (00849771052289)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: K-Wire and Steinmann Pin Dispenser
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KI71050
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771052289
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use
Previous DI: 00849771034858

Device Description: K-Wire and Steinmann Pin Dispensers, No Dispensing Hole, 24 gauge, holds k-wires 19-inch long

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):	No
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?
61918	Orthopaedic bone pin container	A non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: 8350c027-0a69-48e5-ba8c-97242b685300
Public Version Date: June 29, 2023
Public Version Number: 2
DI Record Publish Date: January 26, 2023