CONDOR

Basic Information

• Brand Name: CONDOR
• Primary DI: 10194484320451
• Version / Model: 2VLY3V
• Company Name: GRAINGER INTERNATIONAL, INC.
• Labeler DUNS: 053618240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 0de043b0-9019-486a-95ec-f5f95f827107

Device Description

Disposable Gloves,Nitrile,M,PK100

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61886	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A, or cyclosporine, in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20194484320458	GS1	Box	10	In Commercial Distribution
Primary	10194484320451	GS1
Unit of Use	00194484320454	GS1

Premarket Submissions

Submission Number	Supplement Number
K212578	000