AccessGUDID - DEVICE: Key Surgical K-Wire and Pin Covers (00849771003649)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical K-Wire and Pin Covers
Version or Model: C-093
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C093
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771003649
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Pin Covers, Sterile, Gray, .093-inch, 2.4mm, 2 per package

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":	Yes
For Single-Use:	Yes
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?
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: .093 Inch

Device Record Status

Public Device Record Key: 452ac941-3749-420a-839c-c8a871006b7c
Public Version Date: March 12, 2024
Public Version Number: 4
DI Record Publish Date: December 09, 2020