N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00614138115491
• Version / Model: 4023P8
• Catalog Number: 4023P8
• Company Name: TETRA MEDICAL SUPPLY CORP.
• Labeler DUNS: 047580212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-04
• Public Version: 1
• Public Version Date: 2022-08-12
• Public Version Status: New
• Public Device Record Key: 69fe2ff8-a3f8-4d00-a6a6-561f5e188590

Device Description

FOREARM SPLINT PAD LG/RT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42874	Hand/finger splint, reusable	A prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614138115491	GS1

Customer Contacts

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