AccessGUDID - DEVICE: K-Wire and Steinmann Pin Dispensers (10849771043154)

GUDID

Device Identifier (DI) Information

Brand Name: K-Wire and Steinmann Pin Dispensers
Version or Model: KI-049-05PT1.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KI04905PT15
Company Name: KEY SURGICAL, INC.

Primary DI Number: 10849771043154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: K-Wires, Single Trocar, 1.5cm partially threaded, 0.049-inch (1.25mm) diameter, 5.90-inch (150mm) length

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?
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
Outer Diameter: 0.049 Inch
Length: 5.9 Inch

Device Record Status

Public Device Record Key: 39de231e-2ef9-487f-a07f-9d24eeff1845
Public Version Date: November 30, 2022
Public Version Number: 1
DI Record Publish Date: November 22, 2022