Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095604659
• Version / Model: 2850
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 3
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 6da2bf3e-ee77-4d97-bf6d-259bfb89c4c7

Device Description

Inoculation Loop, Rigid, 10uL & 1uL, with Calibration Certificate, STERILE, White, Individually Wrapped

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
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15155	Inoculating tool IVD, manual	A hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender handle with an attached loop or swab on the proximal end to collect and transfer a specimen into the culture medium. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840095604659	GS1
Unit of Use	00840095610841	GS1
Package	00840095604666	GS1	Case	12	In Commercial Distribution