Duns Number:332474605
Device Description: Includes one 25-pack of each Leak Stop Channel Marker - Channels 1-12 with UDIs: 108163890 Includes one 25-pack of each Leak Stop Channel Marker - Channels 1-12 with UDIs: 10816389028507; 10816389028514; 10816389028521; 10816389028538; 10816389028545; 10816389028552; 10816389028569; 10816389028576; 10816389028583; 10816389028590; 10816389028606; 10816389028613;
Catalog Number
GM11010510
Brand Name
Leak Stop Channel Marker Set, 1-12
Version/Model Number
GM11010510
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K152018
Product Code
JAQ
Product Code Name
System, applicator, radionuclide, remote-controlled
Public Device Record Key
86afcef6-b73f-49ca-86d1-6b8d2f90003a
Public Version Date
June 27, 2022
Public Version Number
3
DI Record Publish Date
December 04, 2020
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. | 713 |