Duns Number:268845728
Device Description: Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 Monopolar protection sleeve is designed to be installed onto Monopolar Arms B-1304, B-1505 and B-1506 and to remain there for the duration of the surgical procedure. It is provided non-sterile and is single use; it must be sterilize before the use. Its purpose is to protect the gear mechanism from its environment and guarantee the electrical insulation. It prevents the distal part of the arms (except for the tip) from coming into contact with the patient's tissues, thereby preventing the risk of lesions and burning subsequent to such contact.
Catalog Number
-
Brand Name
Monopolar protection sleeve
Version/Model Number
M-1304
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
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
K191878
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
607ef8ca-39a2-4f8d-a9f8-718bad7d16ff
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 |