AccessGUDID - DEVICE: Y-KNOT ONESTEP (20845854902148)

GUDID

Device Identifier (DI) Information

Brand Name: Y-KNOT ONESTEP
Version or Model: Y1SCG2D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Y1SCG2D
Company Name: Conmed Corporation

Primary DI Number: 20845854902148
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Y-Knot OneStep Guide, Curved, Disposable

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?
57789	Surgical drill guide, single-use	A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, 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
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cefc7bde-21b6-4239-bd11-7ce54804823d
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: June 24, 2020