Duns Number:089645059
Device Description: 6.0 X 120MM DRILL SLEEVE
Catalog Number
303-6005
Brand Name
6.0 X 120MM DRILL SLEEVE
Version/Model Number
303-6005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
6afda73a-858c-4d9e-8de7-a613f38b9b31
Public Version Date
February 24, 2022
Public Version Number
1
DI Record Publish Date
February 16, 2022
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 | 60 |
2 | A medical device with a moderate to high risk that requires special controls. | 846 |