Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095600262
• Version / Model: 109120L
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-11-27
• Public Version: 1
• Public Version Date: 2019-12-05
• Public Version Status: New
• Public Device Record Key: 1cbc1030-0ccd-443b-bc23-823b1a6718e6

Device Description

Container, Fecal, 30mL, Attached Screw Cap with Spoon, PP, Conical Bottom, Self-Standing, Attached ID Label, 50/Bag, 10 Bags/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: No
• 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
57907	Faecal specimen container IVD, no additive	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a faecal specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840095600262	GS1
Unit of Use	00840095608671	GS1