AccessGUDID - DEVICE: Novo Surgical (00842331117275)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: 5560-53
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5560-53
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331117275
Issuing Agency: GS1
Commercial Distribution End Date: April 18, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: Debakey Aortic Aneurysm Clamp, jaws 7.5 cm, 1x2 debakey teeth, 9-1/2" (24.0 cm)

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?
35595	Bone clamp traction bar	A manual surgical device designed to bridge two opposing bone clamps being used as a pair, one on either side of a fracture (the proximal and distal segment of a fractured bone) that is being approximated during orthopaedic surgery. It is attached to the stem of each of the bone clamps and using its screw mechanism, the fracture is drawn together by the surgeon. It is typically made of high-grade stainless steel and is designed for this function only. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	CLAMP, VASCULAR

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
Length: 24 Centimeter

Device Record Status

Public Device Record Key: 002b03dc-bd11-4886-ac38-ef78b8ac4451
Public Version Date: April 21, 2025
Public Version Number: 3
DI Record Publish Date: September 23, 2016