Duns Number:081277700
Device Description: Pratt Uterine Dilator 11-1/2", Double-Ended, 13 Fr and 15 Fr
Catalog Number
30-560-1315
Brand Name
Integra® Miltex®
Version/Model Number
30-560-1315
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"
-
For Single-Use
-
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
-
Product Code
HDQ
Product Code Name
DILATOR, CERVICAL, FIXED SIZE
Public Device Record Key
3bc7cbb5-35fa-4e36-b389-dbe70909f9fe
Public Version Date
February 05, 2020
Public Version Number
3
DI Record Publish Date
February 26, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |