Duns Number:185524860
Device Description: 5.0mm Spacer, Sterile Pack of 50
Catalog Number
7030550
Brand Name
SourceLink 5.0mm Spacer
Version/Model Number
7030550
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K023210,K023210
Product Code
KXK
Product Code Name
Source, brachytherapy, radionuclide
Public Device Record Key
b1dcb71e-0053-4f3c-9f07-e5b1af588030
Public Version Date
October 31, 2022
Public Version Number
2
DI Record Publish Date
August 06, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |