Duns Number:832696038
Device Description: CARROL-TYPE PERIOSTEAL ELEVATOR, DOUBLE ENDED, ROUND BLADE 3MM WIDE, FLAT 10MM WIDE OVERAL CARROL-TYPE PERIOSTEAL ELEVATOR, DOUBLE ENDED, ROUND BLADE 3MM WIDE, FLAT 10MM WIDE OVERALL LENGTH 5-1/2"(14CM)
Catalog Number
NL1131
Brand Name
V. Mueller
Version/Model Number
NL1131
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
2d828ba9-1e0b-4b46-9356-64bacc76ef2d
Public Version Date
December 04, 2020
Public Version Number
4
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 |