AccessGUDID - DEVICE: NA (07613327115147)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0940000000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0940-000-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327115147
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Cast Cutter

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):	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?
16340	Cast cutter, electrically-powered	A hand-held, electrically-powered device designed for cutting the plaster or synthetic material used to form casts typically during the removal process. The proximal end is usually cylindrical, forming the handle of the device, whilst the distal end terminates in a rounded, half moon-like, or circular blade capable of cutting the material used to form casts. The cutting capability of the blade is provided by an electric motor in the handle which vibrates or rotates the blade. Cutting is effected by vibration or rotation rather than sawing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAB	SAW, POWERED, AND ACCESSORIES

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3eaa4717-7798-4e82-99c9-48fba0959e49
Public Version Date: April 16, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2018