Duns Number:832696038
Device Description: SLUDER-JANSEN MOUTH GAG CURVED ARMS, RATCHET LOCK BLADE 20MM WIDE. OVERALL LENGTH 5-1/2"(1 SLUDER-JANSEN MOUTH GAG CURVED ARMS, RATCHET LOCK BLADE 20MM WIDE. OVERALL LENGTH 5-1/2"(14CM)
Catalog Number
MO120
Brand Name
V. Mueller
Version/Model Number
MO120
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
KBN
Product Code Name
GAG, MOUTH
Public Device Record Key
74406668-6c88-44f0-9a82-20f8ceb8f323
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 06, 2019
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 |