Duns Number:832696038
Device Description: FLETCHER-VAN DOREN UTERINE POLYP SPONGE HOLDING FORCEPS DOUBLE CURVED OVERALL LENGTH 9-1/2 FLETCHER-VAN DOREN UTERINE POLYP SPONGE HOLDING FORCEPS DOUBLE CURVED OVERALL LENGTH 9-1/2"(24.1CM)
Catalog Number
GL1805
Brand Name
V. Mueller
Version/Model Number
GL1805
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
HCZ
Product Code Name
FORCEPS, SURGICAL, GYNECOLOGICAL
Public Device Record Key
a0f8a816-7962-48fc-bf05-e23916be9388
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 |