Duns Number:091301184
Device Description: Two flexible gas lines, that are able to withstand up to 150 PSI. Used for the Kronner Low Two flexible gas lines, that are able to withstand up to 150 PSI. Used for the Kronner Low Profile Scope Holder. Sterilized for single-use.
Catalog Number
-
Brand Name
Kronner Low Profile Scope Holder Gas Line Set
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000663,K000663
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
9788111d-06fb-4c03-a3a5-4293a0ba6bae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 21, 2017
Package DI Number
00856589007066
Quantity per Package
25
Contains DI Package
00856589007011
Package Discontinue Date
-
Package Status
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |