Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094359144
• Version / Model: 35-914/20
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-11
• Public Version: 1
• Public Version Date: 2024-01-19
• Public Version Status: New
• Public Device Record Key: 4146af3c-0297-4b65-a08f-268023d2431d

Device Description

Freer Elevator Double End

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
KDC	INSTRUMENT, SURGICAL, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66273	Bone lever/elevator, single-use	A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094359141	GS1	Case	20	In Commercial Distribution
Primary	00630094359144	GS1