NuGrip CMC

Basic Information

• Brand Name: NuGrip CMC
• Primary DI: 00885556857779
• Version / Model: NUG-443-20S
• Catalog Number: NUG-443-20S
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-22
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 8d66bc4f-a05b-49dc-b175-a9b4431aed46

Device Description

NUGRIP SZ. 20S

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYI	Prosthesis, wrist, carpal trapezium	Orthopedic	888.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33743	Carpal trapezium prosthesis	A sterile implantable device designed to replace a partly-resected trapezium bone of the wrist typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device made of silicone elastomer. Short-term fixation is typically performed with sutures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556857779	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112278	000