Duns Number:332474605
Catalog Number
GM11010030
Brand Name
Length cutting gauge, 250mm for implant tubes and breast applicators up to 6 Fr.
Version/Model Number
GM11010030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983436
Product Code
JAQ
Product Code Name
System, applicator, radionuclide, remote-controlled
Public Device Record Key
b9390183-2e9f-403c-bbd2-d585d75a5c14
Public Version Date
November 25, 2021
Public Version Number
1
DI Record Publish Date
November 17, 2021
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 |