Inoculating Loop 10ul Typenex

Basic Information

• Brand Name: Inoculating Loop 10ul Typenex
• Primary DI: 06973267012168
• Version / Model: 10ul,rigid,dark blue, LP0202
• Company Name: ZHEJIANG RUNLAB TECHNOLOGY CO., LTD
• Labeler DUNS: 529124298
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-10
• Public Version: 1
• Public Version Date: 2023-10-18
• Public Version Status: New
• Public Device Record Key: 53247a39-0bb1-4d48-b8c9-c71102056c3c

Device Description

10ul,rigid,dark blue, LP0202

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
64876	Specimen transfer scooping tool IVD	A hand-held manual instrument intended to be used to scoop a clinical specimen or microbial isolate for transfer from a primary vessel to a secondary container (e.g., from a specimen collection receptacle to a reagent tube, or from a culture medium to a general laboratory test tube) for subsequent in vitro diagnostic analysis and/or other investigation. It is typically a slender device with a loop, rake, or ball at the distal end used to scoop and transfer the clinical specimen or microbial isolate. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06973267012144	GS1	inner bag	20	In Commercial Distribution
Primary	06973267012168	GS1
Package	06973267012120	GS1	inner box	50	In Commercial Distribution
Package	16973267012127	GS1	case	6	In Commercial Distribution