Duns Number:268845728
Device Description: The monopolar maryland are reusable (40 uses) endoscopic instrument. It is connected to th The monopolar maryland are reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the single-use Monopolar Protection sleeve (ref. M-1304). Each Arm is composed of an insulated shaft, a connection cover and an articulated instrument that provides distal mobility1. Tilting the tip with respect to the axis of the shaft2. Rotation of the tip around its own axis3. Opening-closing the tip/needle holder
Catalog Number
-
Brand Name
Arm Monopolar Maryland
Version/Model Number
B-1505
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
K191878
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
1b3af5fe-ad9e-4498-81ee-e7bfaf341aa5
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |