Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094171258
• Version / Model: 17125/10
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: 2aeb3da7-8121-4f5d-9c41-11c4174156d8

Device Description

Metal Thimble

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
41138	Surgical finger guard	A cap intended to be placed over the gloved, non-dominant index finger of a surgical staff hand to provide protection from blood contamination and to reduce accidental needle-sticks and scalpel cuts during a surgical procedure. It is a tough, thimble-like shell with a repellent surface designed with specific features (e.g., notches, protrusions) to help guide a needle tip insertion while protecting the fingertip of the wearer. It is typically used for blunt tissue dissection, to prevent blood vessel punctures, and for interventions such as bladder neck suspension, episiotomy repair and colporrhaphy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094171255	GS1	Case	10	In Commercial Distribution
Primary	00630094171258	GS1