AccessGUDID - DEVICE: De Soutter Medical (05051471161597)

GUDID

Device Identifier (DI) Information

Brand Name: De Soutter Medical
Version or Model: 18680
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18680
Company Name: DE SOUTTER MEDICAL LIMITED

Primary DI Number: 05051471161597
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458064144 *Terms of Use

Device Description: STERNUM GUARD - SPECIAL

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?
44981	Sternum saw blade guide	A protective device with a bulbous distal end used together with a sternal saw blade when cutting open the sternum (the breastbone) during cardiovascular surgery. The saw blade will operate within the confines of this device that protects the underlying organs from contact with the end of the reciprocating blade. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GET	Motor, Surgical Instrument, Pneumatic 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: 57c4e7ff-4e54-46e9-bcf0-8ec495c04b9c
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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