AccessGUDID - DEVICE: Novo Surgical (00842331103438)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: 5644-46T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5644-46T
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331103438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: CV Elite - Titanium Satinsky Vena Cava Clamp, debakey jaws, 10" (25.4 cm), 2.5 cm jaws

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?
34951	Bulldog clamp	A manual surgical instrument with heavily serrated jaws at the working end designed to grasp, join, compress or support an organ, vessel or tissue. This instrument is typically made of high-grade stainless steel and comes in two main designs: 1) a flat, pincer-like design with jaws that close to a set opening and which have serrated finger grips or opposing handles at the proximal end which, when depressed by the operator, release the clamp; or 2) a self-retaining, scissors-like design with ring handles; both may have various straight, angled or curved blades at the working end. This is a reusable device.	Obsolete	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: 25.4 Centimeter

Device Record Status

Public Device Record Key: e746c44a-8b87-4675-9a99-3c493b16837f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016