AccessGUDID - DEVICE: BD SurePath (00382904910952)

GUDID

Device Identifier (DI) Information

Brand Name: BD SurePath
Version or Model: 491095
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 491095
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904910952
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: SurePath® GYN Preservative Vial Kit with Cervex-Brush

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?
65667	Endocervical specimen cytological examination kit IVD	A collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. 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 [?]
P970018	002

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
Height: 37 Inch
Width: 44 Centimeter
Length: 44 Centimeter

Device Record Status

Public Device Record Key: 2c8410a1-ad5c-4f88-b51b-2e76c5605e3d
Public Version Date: May 02, 2022
Public Version Number: 7
DI Record Publish Date: July 22, 2015