AccessGUDID - DEVICE: De Soutter Medical (05051471050709)

GUDID

Device Identifier (DI) Information

Brand Name: De Soutter Medical
Version or Model: 9590
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9590
Company Name: DE SOUTTER MEDICAL LIMITED

Primary DI Number: 05051471050709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458064144 *Terms of Use

Device Description: WRENCH FOR SZ-400 HEAD

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?
44605	Surgical drill chuck key	A hand-held device designed to close and tighten the adjustable jaws of a surgical drill chuck onto a cutting tool, normally a drill bit or other rotational cutting tool, for a firm grip. It is inserted into any one of three side holes that are spaced around the inner barrel of the chuck, and will engage the geared portion of the outer barrel. When rotated, the key will turn the outer barrel, which in turn closes and locks the jaws of the chuck upon the cutting tool. To loosen, the reverse action is taken. It is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	Motor, Surgical Instrument, 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: ce89ed1c-78b3-4e93-ae50-df14427070ed
Public Version Date: December 06, 2022
Public Version Number: 1
DI Record Publish Date: November 28, 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
No Package DIs found

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

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