AccessGUDID - DEVICE: GLOBAL STEPTECH (10603295525530)

GUDID

Device Identifier (DI) Information

Brand Name: GLOBAL STEPTECH
Version or Model: 223000361
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 223000361
Company Name: DEPUY (IRELAND)

Primary DI Number: 10603295525530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989365556 *Terms of Use

Device Description: GLOBAL STEPTECH ANCHOR PEG GLENOID STEPTECH OSCL RASP SM +5 LINV FITS: CONMED MICROFREE AND HALL MICROPOWER SMALL +5MM

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):	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?
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
KIJ	Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment

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
No Device Sizes

Device Record Status

Public Device Record Key: c86bd247-68f0-4797-8a69-f54bd55e099a
Public Version Date: February 22, 2021
Public Version Number: 1
DI Record Publish Date: February 14, 2021