AccessGUDID - DEVICE: STRYKER 2000 (10845854000595)

GUDID

Device Identifier (DI) Information

Brand Name: STRYKER 2000
Version or Model: 5072-151
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5072-151
Company Name: Conmed Corporation

Primary DI Number: 10845854000595
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.82 X 85.67 X 1.19 MM (.047 IN)

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?
43376	Surgical saw blade, sagittal, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge 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 the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 24.82 Millimeter
Length: 85.67 Millimeter
Height: 1.19 Millimeter
Height: 0.047 Inch

Device Record Status

Public Device Record Key: 06c4f201-78b7-461d-8e50-f40aa36b6580
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020