Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331182037
• Version / Model: 9031-12
• Catalog Number: 9031-12
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-14
• Public Version: 1
• Public Version Date: 2022-11-22
• Public Version Status: New
• Public Device Record Key: 8c2e2e44-9560-473e-a2ad-17a7a3194048

Device Description

laparascopic clips/appliers, laparoscopic clip applier, straight, ultra grip, 7 1/2" (19.0 cm), for large clips, green_x000D__x000D_Caution: _x000D__x000D_To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes/Bipolar Forceps._x000D__x000D_For all monopolar electrodes/Bipolar Forceps, the useful life of this product is = 50 cycles and = 2 years._x000D__x000D_Please read complete Intructions for Use prior to use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZP	Clip, Implantable	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32581	Surgical clip rack	A device typically designed as a container used to hold and protect implantable clips during the sterilization process. The rack also serves to hold the clips in the proper geometric orientation to permit mating with the clip applier used during the clip's application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331182037	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]