AccessGUDID - DEVICE: BD SurePath™ PreCoat Slides (30382904912483)

GUDID

Device Identifier (DI) Information

Brand Name: BD SurePath™ PreCoat Slides
Version or Model: 491248
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 491248
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904912483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 96
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD SurePath™ PreCoat Slides

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
KEW	Slides, Microscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a07146b-dc85-43e6-b5e7-81824c42fe8b
Public Version Date: September 23, 2024
Public Version Number: 6
DI Record Publish Date: September 08, 2017