Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094163604
• Version / Model: 16360/25
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-13
• Public Version: 1
• Public Version Date: 2023-09-21
• Public Version Status: New
• Public Device Record Key: 01338437-3f51-44bd-8845-3f46751957d0

Device Description

Traction Rope

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILZ	ACCESSORIES, TRACTION	Physical Medicine	890.5925	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62664	Traction cord	A length of synthetic fibre (e.g., nylon) intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically intended to be cut to the desired length, threaded around pulleys, and knotted where needed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094163601	GS1	Case	25	In Commercial Distribution
Primary	00630094163604	GS1