AccessGUDID - DEVICE: HALL (10845854033425)

GUDID

Device Identifier (DI) Information

Brand Name: HALL
Version or Model: 00507165000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5071-650
Company Name: Conmed Corporation

Primary DI Number: 10845854033425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 20845854033422

Device Description: LARGE BONE, HALL BLADE, OSCILLATING, 49 X 63 X 0.6 MM (.024 INCH)

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?
46476	Surgical saw blade, oscillating, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

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
Width: 49 Millimeter
Length: 63 Millimeter
Height: 0.024 Inch
Height: 0.6 Millimeter

Device Record Status

Public Device Record Key: 5ac07de3-95f1-4681-8e3b-497c780cf2bb
Public Version Date: July 30, 2024
Public Version Number: 3
DI Record Publish Date: February 14, 2023