Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094049090
• Version / Model: 4909/20
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-24
• Public Version: 1
• Public Version Date: 2024-02-01
• Public Version Status: New
• Public Device Record Key: badb9a6e-74f4-46d5-a9b6-629d01dd7d40

Device Description

Silastic Wires Keepers

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
GAX	TOURNIQUET, NONPNEUMATIC	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37825	Antimicrobial orthopaedic bone pin/wire sleeve	A small diameter plastic tube placed over the orthopaedic pins or wires used during the external fixation of bones, to inhibit bacterial colonization on or around the pins or wires during healing. It is typically made of polyurethane and is coated on the inner and outer surfaces with an antimicrobial agent. It is available in various diameters and/or designs to match orthopaedic pin/wire diameters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094049097	GS1	Case	20	In Commercial Distribution
Primary	00630094049090	GS1