AccessGUDID - DEVICE: Novo Surgical (00842331102981)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: 0806-05I
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0806-05I
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331102981
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: CV Elite - Suction Bipolar Bayonet-Style Forceps, insulated, w/ suction, 1.4 mm tips, 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?
47848	Open-surgery electrosurgical handpiece/electrode, bipolar, reusable	A rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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: 8ff162cb-59a1-4c0f-9297-1d37189131a2
Public Version Date: May 02, 2025
Public Version Number: 3
DI Record Publish Date: September 23, 2016