Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095657747
• Version / Model: 6102S-R
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2020-10-08
• Public Version: 1
• Public Version Date: 2020-10-16
• Public Version Status: New
• Public Device Record Key: 19388ce7-47b8-4218-bf0e-97953521bab6

Device Description

16x101mm tube, separate red screwcap, sterile, self-standing,200 tube/bag,1000cap/bag,case liner.

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46238	General laboratory container, single-use, sterile	A sterile container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840095657754	GS1
Primary	00840095657747	GS1