AccessGUDID - DEVICE: Key Surgical General Instruments (00849771011705)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical General Instruments
Version or Model: KI-46-647
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771011705
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: German Stainless Steel Pliers, Pin Cutter, 7.5-inch cannulated, .062-inch max

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?
32885	Wire cutter	A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. 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: 8634ec72-c5fc-45d0-bc46-a7a2ef18bfa8
Public Version Date: January 24, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2020