AccessGUDID - DEVICE: De Soutter Medical (05051471026544)

GUDID

Device Identifier (DI) Information

Brand Name: De Soutter Medical
Version or Model: 609103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 609103
Company Name: DE SOUTTER MEDICAL LIMITED

Primary DI Number: 05051471026544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458064144 *Terms of Use

Device Description: PS6 - POWER SUPPLY 100V SIGMAX

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?
45590	Cast cutter vacuum system	An assembly of devices designed to collect the dust produced by a cast cutter (e.g., pneumatic or electric cast saw) from the workspace environment by suction during the cast removal procedure. It typically consists of a motorized vacuum pump, a filter, and a collection container (e.g., bag or cartridge). It is typically a portable unit and its motor may run concurrently with the saw motor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGH	Instrument, Cast Removal, Ac-Powered

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 332150b8-9b75-4d7c-8d1a-ee334827facf
Public Version Date: December 05, 2022
Public Version Number: 1
DI Record Publish Date: November 25, 2022