Duns Number:122561087
Device Description: SurePath® GYN Preservative Vial Kit: 10 mL SurePath® Preservative Fluid Collection Vials SurePath® GYN Preservative Vial Kit: 10 mL SurePath® Preservative Fluid Collection Vials (500)
Catalog Number
490527
Brand Name
SurePath Preservative Fluid Collection Vial
Version/Model Number
490527
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2022
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P970018,P970018,P970018
Product Code
MKQ
Product Code Name
Processor, Cervical Cytology Slide, Automated
Public Device Record Key
50727383-baaf-4989-b37b-20ddaef70346
Public Version Date
October 29, 2021
Public Version Number
8
DI Record Publish Date
September 08, 2017
Package DI Number
30382904905270
Quantity per Package
20
Contains DI Package
10382904905276
Package Discontinue Date
December 31, 2022
Package Status
In Commercial Distribution
Package Type
Shelf Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |