WELLBRACE

Basic Information

• Brand Name: WELLBRACE
• Primary DI: 07798094540078
• Version / Model: 1104-502 U XS
• Company Name: PANTYMED S.A.
• Labeler DUNS: 971365986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 1
• Public Version Date: 2024-01-15
• Public Version Status: New
• Public Device Record Key: a4a3b6e0-8f51-4f07-8f7b-fc10e9317443

Device Description

CABESTRILLO DE RED- WELLBRACE - XS

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILI	Sling, Arm	Physical Medicine	890.3640	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
Primary	07798094540078	GS1