Duns Number:109935591
Device Description: 3.8mm Drill w/6mm Shank
Catalog Number
IM550038
Brand Name
Sequel Medical
Version/Model Number
IM550038
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
f416b0dc-41eb-4f37-a22b-f81d996c0ea5
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
February 17, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 172 |