AccessGUDID - DEVICE: ThinPrep Imaging System (15420045500891)

GUDID

Device Identifier (DI) Information

Brand Name: ThinPrep Imaging System
Version or Model: ThinPrep Imaging System Review Scope
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71062-001
Company Name: Hologic, Inc.

Primary DI Number: 15420045500891
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: A microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor.

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:	No
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?
35484	Basic light microscope	A magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNM	READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020002	007

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
Storage Environment Temperature: between -28 and 50 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7cb0048-35c1-4f1f-a2a3-635e59ff7431
Public Version Date: May 30, 2024
Public Version Number: 5
DI Record Publish Date: September 02, 2014