NuGrip CMC

Basic Information

• Brand Name: NuGrip CMC
• Primary DI: 00885556857656
• Version / Model: CMC-DIS-HAL
• Catalog Number: CMC-DIS-HAL
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: d299a8a0-4399-4faa-9f18-ed4d5f7f4129

Device Description

CMC DISPOSABLE PACK FOR LINVATEC/HALL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAB	SAW, POWERED, AND ACCESSORIES	General, Plastic Surgery	878.4820	1
HTZ	INSTRUMENT, CUTTING, ORTHOPEDIC	General, Plastic Surgery	878.4800	1
HTT	BURR, ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45198	ENT stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during ear/nose/throat (ENT) surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556857656	GS1

Customer Contacts

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