N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00614138107342
• Version / Model: 1285-A4
• Catalog Number: 1285-A4
• Company Name: TETRA MEDICAL SUPPLY CORP.
• Labeler DUNS: 047580212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-02
• Public Version: 1
• Public Version Date: 2022-08-10
• Public Version Status: New
• Public Device Record Key: 70b766ff-04fa-4568-aae5-03e608a16529

Device Description

COMPRESSION ANKLE SUPPORT, XL

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
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44481	Ankle binder, reusable	A strip or roll of fabric or plastic material designed to be wrapped around the ankle to help stabilize and support the joint. It does not include a rigid support (i.e., not an ankle/foot orthosis) and is not a tubular support bandage. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614138107342	GS1

Customer Contacts

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