NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982199461
• Version / Model: 394.052
• Catalog Number: 394052
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 6
• Public Version Date: 2022-05-02
• Public Version Status: Update
• Public Device Record Key: 8d388200-a6b8-4649-9608-443f1a1fea92

Device Description

WRIST COVER

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• 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
IPM	COVER, LIMB	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43222	Limb-worn device hygienic cover	A device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H6793940520	HIBCC
Primary	10886982199461	GS1

Customer Contacts

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