Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094171012
• Version / Model: 17100/16
• 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: f7845f5a-d7ae-4e5c-a005-449ee796d738

Device Description

Bone Jar & Napak Bag

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
KDD	Kit, surgical instrument, disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61666	Surgical container holder	A non-sterile device intended to hold a container (e.g., jar, cup, beaker, vial, test-tube) during a surgical procedure to improve its stability and prevent overturning and spillage. It is typically a formed block with an appropriately shaped opening to accept a suitably sized container(s); it is not a test tube rack. This is a single-use device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094171019	GS1	Case	16	In Commercial Distribution
Primary	00630094171012	GS1