Duns Number:317654283
Device Description: Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end Olympus-ID: A5798
Catalog Number
1298-00-05OL
Brand Name
Exchangeable suction-Irrigation tube
Version/Model Number
1298-00-05OL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
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"
Yes
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
cdb7ded2-9a5c-4029-be16-ed64c363730a
Public Version Date
March 16, 2021
Public Version Number
3
DI Record Publish Date
September 08, 2016
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |