Duns Number:832696038
Device Description: VITAL FRENCH EYE NEEDLE HOLDER, TUNG CARB INSERTS 2500 TEETH PER SQUARE INCH OVERALL LENGT VITAL FRENCH EYE NEEDLE HOLDER, TUNG CARB INSERTS 2500 TEETH PER SQUARE INCH OVERALL LENGTH 6-1/4"(15.9CM)
Catalog Number
SU16145
Brand Name
V. Mueller
Version/Model Number
SU16145
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
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
b16c9075-3ee3-4642-98c8-f58dbb6cc559
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
September 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 |