Duns Number:657528899
Device Description: Reusable Cervical Dilators may be reused after disinfecting. They are made of medical-gra Reusable Cervical Dilators may be reused after disinfecting. They are made of medical-grade Teflon.
Catalog Number
-
Brand Name
NA
Version/Model Number
OS260BA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HDQ
Product Code Name
Dilator, Cervical, Fixed Size
Public Device Record Key
ae729520-7bd2-4ef0-947e-6882a4c1bb9c
Public Version Date
June 25, 2020
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
04715309125090
Quantity per Package
25
Contains DI Package
04715309122099
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |