Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095608299
• Version / Model: 6527FL
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 1
• Public Version Date: 2019-12-04
• Public Version Status: New
• Public Device Record Key: bed11eb1-d145-4971-8a0a-3a39116a62eb

Device Description

Pre-Filled Container with Click Close Lid: Tite-Rite, 120mL (4oz), PP, Filled with 60mL of 10% Neutral Buffered Formalin, Attached Hazard Label, 24/Box, 4 Boxes/Unit

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57926	General tissue specimen container IVD, formal saline	A covered plastic receptacle containing 10% formal saline preservative solution (formalin) intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) for analysis and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840095608299	GS1
Unit of Use	00840095612067	GS1