Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094172507
• Version / Model: 17250/48
• 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: c786ca0e-481b-4bcc-892e-7106f7bdd79b

Device Description

Petri Dish Culture

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
KIZ	DISH, TISSUE CULTURE	Hematology	864.2240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43344	Tissue culture/microbiology petri dish, single-use	A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094172504	GS1	Case	48	In Commercial Distribution
Primary	00630094172507	GS1