AccessGUDID - DEVICE: ThinPrep Pap Test (15420045504004)

GUDID

Device Identifier (DI) Information

Brand Name: ThinPrep Pap Test
Version or Model: ThinPrep Pap Test Physician Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Hologic, Inc.

Primary DI Number: 15420045504004
Issuing Agency: GS1
Commercial Distribution End Date: September 16, 2014
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: No description.

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:	Yes
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?
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.	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: 4c17af15-c5d7-4f94-b88e-9efb8792da33
Public Version Date: October 14, 2024
Public Version Number: 6
DI Record Publish Date: September 15, 2014