AccessGUDID - DEVICE: ThinPrep Imaging System (25420045501093)

GUDID

Device Identifier (DI) Information

Brand Name: ThinPrep Imaging System
Version or Model: ThinPrep® Imaging System Microscope Slides, 100pk
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASY-07317
Company Name: Hologic, Inc.

Primary DI Number: 25420045501093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: Glass slides or use with ThinPrep® processors and ThinPrep® Imaging Systems for gynecological specimens.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57951	Cervical cytology microscopy slide IVD	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of a cervical cytology smear for analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKQ	Processor, cervical cytology slide, automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950039	028

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ca8077f1-eecc-48de-bcb1-b650adecbcd9
Public Version Date: April 08, 2024
Public Version Number: 6
DI Record Publish Date: September 11, 2014