Duns Number:268845728
Device Description: Protection sleeve 2090-MDS is designed to be placed on the Needle holder arm and to remain Protection sleeve 2090-MDS is designed to be placed on the Needle holder arm and to remain there for the duration of the surgical procedure. Its purpose is to protect the gear mechanism from its environment. It also helps prevent the gears from coming into contact with the patient's tissues, thereby preventing the risk of lesion formation subsequent to such mechanical contact. It is provided non-sterile and is single use; it must be sterilize before the use.
Catalog Number
-
Brand Name
Protection sleeve
Version/Model Number
2090-MDS
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
a207ba58-9005-44c2-9792-9d41d3458d3d
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 |