Duns Number:832696038
Device Description: GRAVES VAGINAL SPECULA WITH SMOKE EVACUATION TUBE MEDIUM, BLACK COATING FINISH 4 X 1-3/8"( GRAVES VAGINAL SPECULA WITH SMOKE EVACUATION TUBE MEDIUM, BLACK COATING FINISH 4 X 1-3/8"(10.2 X 3.5CM)
Catalog Number
LS11
Brand Name
V. Mueller
Version/Model Number
LS11
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
HDF
Product Code Name
SPECULUM, VAGINAL, METAL
Public Device Record Key
f75286ad-ac65-4e85-aa46-a2f14b08a4e3
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 30, 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 |