Duns Number:711789789
Catalog Number
-
Brand Name
ENDOEYE RIGID LENS CLEANING SHEATH FOR 10MM 0DEGREES
Version/Model Number
OLYMPUS LC-S190-10-0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 19, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
351a3436-41d7-41f6-b10d-bdefc46632b5
Public Version Date
August 22, 2022
Public Version Number
5
DI Record Publish Date
March 31, 2017
Package DI Number
04953170366864
Quantity per Package
5
Contains DI Package
04953170366918
Package Discontinue Date
August 19, 2022
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |