Duns Number:040729840
Device Description: MENISCOTOME MINIATURE V-SHAPED BLADE FLAT HANDLE
Catalog Number
1103-2063
Brand Name
MINIATURE MENISCOTOME
Version/Model Number
1103-2063
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
HTS
Product Code Name
KNIFE, ORTHOPEDIC
Public Device Record Key
2e725cdc-f25a-458d-a88d-a8dfb81aa2e2
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
September 21, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |