ThinPrep

Basic Information

• Brand Name: ThinPrep
• Primary DI: 15420045508460
• Version / Model: UroCyte Vial
• Catalog Number: 70990-002
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-30
• Public Version: 4
• Public Version Date: 2023-02-01
• Public Version Status: Update
• Public Device Record Key: 3d397652-9efb-4708-bca6-0dc4acc83021

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LEA	PRESERVATIVE, CYTOLOGICAL	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46023	Non-evacuated urine specimen container IVD, no additive	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine 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	15420045508460	GS1
Package	65420045508465	GS1	BOX	4	In Commercial Distribution
Package	45420045508461	GS1	VIAL	25	In Commercial Distribution
Package	55420045508468	GS1	BOX	2	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius