Inoculating Loop Typenex

Basic Information

• Brand Name: Inoculating Loop Typenex
• Primary DI: 06973267011031
• Version / Model: 1ul, Flexible, Blue
• Catalog Number: LP0103
• 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: 2023-07-27
• Public Version: 2
• Public Version Date: 2023-09-01
• Public Version Status: Update
• Public Device Record Key: 6b487137-d417-45ac-9a1d-cb3fce5f791e

Device Description

1ul, Flexible, Blue

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	16973267011038	GS1	case	6	In Commercial Distribution
Primary	06973267011031	GS1
Package	06973267011055	GS1	inner bag	50	In Commercial Distribution