AccessGUDID - DEVICE: ThinPrep (15420045514157)

GUDID

Device Identifier (DI) Information

Brand Name: ThinPrep
Version or Model: APTIMA TUBE PRINTER, THINPREP GENESIS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASY-11355
Company Name: Hologic, Inc.

Primary DI Number: 15420045514157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: Accessory to the Genesis™ processor for automated label printing on a specimen tube.

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?
15110	Microscope slide maker IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue, cytology specimens, or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis.	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	040

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f7111c5-c675-437b-9e17-b26893425a7b
Public Version Date: November 07, 2024
Public Version Number: 2
DI Record Publish Date: May 20, 2024