AccessGUDID - DEVICE: De Soutter Medical (05051471061330)

GUDID

Device Identifier (DI) Information

Brand Name: De Soutter Medical
Version or Model: 11120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11120
Company Name: DE SOUTTER MEDICAL LIMITED

Primary DI Number: 05051471061330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458064144 *Terms of Use

Device Description: CAST BLADE - 38mm SEGMENT TITANIUM NITRIDE

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?
15774	Cast cutter blade	A surgical cutting device intended to be used with a cast removal tool (cast cutter) to provide the cutting edge for cutting through cast material so that this can be removed from the patient. It is formed as a thin, rounded, half moon-like, or circular blade with serrated teeth around its cutting edge. This is a reusable device.	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: e540b802-3a11-4094-ab3a-b0157dc83120
Public Version Date: December 02, 2022
Public Version Number: 1
DI Record Publish Date: November 24, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
15051471061337	5	05051471061330		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES