BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ThinPrep® Pap Test

DI: 15420045501072 · Model: ThinPrep® Pap Test PreservCyt® Sol'n 20ml · Hologic, Inc.

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: ThinPrep® Pap Test
Primary DI: 15420045501072
Version / Model: ThinPrep® Pap Test PreservCyt® Sol'n 20ml
Catalog Number: 70097-001
Company Name: Hologic, Inc.
Labeler DUNS: 018925968
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2014-09-15
Public Version: 8
Public Version Date: 2024-04-11
Public Version Status: Update
Public Device Record Key: 72a5ef55-1195-40d4-b42a-6310b4ebc160

Device Description

For use with the ThinPrep® system to preserve gynecological specimens.

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: No
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
MKQ	Processor, cervical cytology slide, automated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
57952	Cytology specimen container IVD, transport buffer	A covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045501072	GS1
Package	35420045501076	GS1	BOX	10	In Commercial Distribution
Package	25420045501079	GS1	TRAY	25	In Commercial Distribution

Customer Contacts

Phone: +1(800)442-9892
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P950039	028

Storage Conditions

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