Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094175263
• Version / Model: 17526/50
• 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: 37d319a7-4876-41a0-9f2d-e818f197767d

Device Description

Stirring Rod Glass

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
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66103	Assay stirring set IVD	A collection of containers (e.g., test tubes, cuvettes) and magnetic or non-magnetic stirring instruments (e.g., bars, balls) intended to be used to hold and facilitate the stirring/mixing of biological specimens, reagents, buffers, or other materials during in vitro diagnostic testing procedures (e.g., platelet aggregation study, clotting time assay) performed in the laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094175260	GS1	Case	50	In Commercial Distribution
Primary	00630094175263	GS1