Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094176284
• Version / Model: 17628/10
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-28
• Public Version: 1
• Public Version Date: 2023-10-06
• Public Version Status: New
• Public Device Record Key: 0c056aa8-945e-4897-aa7c-f105345f8b4c

Device Description

Microfilament Strands

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
44912	Flexible fibreoptic angioscope, single-use	A sterile endoscope with a very thin, flexible inserted portion intended for the visual examination and treatment of the lumen and patency of blood vessels (especially to evaluate the patency of veins or arteries). It is inserted into the body through an artificial orifice created by an incision made during the procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle (e.g., a fused silica flexible rod that provides sharper images and greater strength than individual strands). It is typically used for visualization of the coronary artery, an arterial bypass procedure with a saphenous vein, or a valvulotomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094176281	GS1	Case	10	In Commercial Distribution
Primary	00630094176284	GS1