Duns Number:832696038
Device Description: LEWIS TONSIL SNARE INCLUDES 12 NO 8 SNARE WIRES WIRE LENGTH 4"(10.2CM) OVERALL LENGTH 10"( LEWIS TONSIL SNARE INCLUDES 12 NO 8 SNARE WIRES WIRE LENGTH 4"(10.2CM) OVERALL LENGTH 10"(25.4CM)
Catalog Number
MO1960
Brand Name
V. Mueller
Version/Model Number
MO1960
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
KBZ
Product Code Name
SNARE, TONSIL
Public Device Record Key
ad787907-13c1-4b66-ba53-e9d5c9c497cf
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 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 |