Duns Number:832696038
Device Description: ECHLIN RONGEUR FORCEPS DBL-ACTION, DUCKBILL PATTERN NARROW, ANG JAWS 3MM X 10MM OVERALL LE ECHLIN RONGEUR FORCEPS DBL-ACTION, DUCKBILL PATTERN NARROW, ANG JAWS 3MM X 10MM OVERALL LENGTH 9" (22.9CM)
Catalog Number
OS1112
Brand Name
V. Mueller
Version/Model Number
OS1112
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
HTX
Product Code Name
RONGEUR
Public Device Record Key
3c27b679-4087-4882-b0a6-4fdcaf2cf4e5
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 10, 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 |