Duns Number:047063695
Device Description: Maryland 45 Degree Inner Shaft 44cm
Catalog Number
262B
Brand Name
Maryland 45 Degree Inner Shaft 44cm
Version/Model Number
263B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 29, 2021
Issuing Agency
In HIBCC
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
740291d5-4549-47ad-bbc9-6ed50e72f3f7
Public Version Date
March 29, 2021
Public Version Number
2
DI Record Publish Date
March 29, 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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 271 |