Duns Number:832696038
Device Description: V. Mueller HANK UTERINE DILATOR SIZE 13-14FR DOUBLE-ENDED OVERALL LENGTH 10-1/2" (26.7CM)
Catalog Number
GL1461-003
Brand Name
V. Mueller
Version/Model Number
GL1461-003
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
43d17a4c-4841-4eb5-81bb-6477346460aa
Public Version Date
February 04, 2022
Public Version Number
2
DI Record Publish Date
August 17, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |