Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094001401
• Version / Model: 107500140/01
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: b7978638-e1a9-4748-9352-069867644d1d

Device Description

Orthomed Arthrodesis Plate

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
61687	Interphalangeal joint arthrodesis implant	A sterile implantable device designed to be inserted across a toe or finger interphalangeal joint, into the contiguous phalanges, to fuse the joint (arthrodesis), typically to correct joints damaged by traumatic, degenerative or rheumatoid arthritis, or other deformities (e.g., hammer toe), or for arthroplasty revision. It is made of metal [(e.g., stainless steel, nickel-titanium alloy (Nitinol)]) and can be of several geometric shapes (e.g., a small rod with barbs at each end, or X-shaped); devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094001408	GS1	Case	1	In Commercial Distribution
Primary	00630094001401	GS1