Duns Number:832696038
Device Description: JUMBO GRIP CUP CURETTE REV ANG SIZE 6, CUP 15MM WIDE OVERALL LENGTH 13-1/4" (33.7CM)
Catalog Number
OS999-006A
Brand Name
V. Mueller
Version/Model Number
OS999-006A
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
HAO
Product Code Name
INSTRUMENT, SURGICAL, NON-POWERED
Public Device Record Key
3096d443-ff68-45dd-b275-1f178afd7acd
Public Version Date
May 07, 2019
Public Version Number
2
DI Record Publish Date
December 05, 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 |