Duns Number:134614411
Device Description: Sterile (15.2 tapered to 7.6 x 183cm) polyethylene accordion-folded cover for use with Sie Sterile (15.2 tapered to 7.6 x 183cm) polyethylene accordion-folded cover for use with Siemens AcuNav ultrasound catheter family connector
Catalog Number
612-113
Brand Name
SwiftLink Transducer Cover
Version/Model Number
612-113
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
K970513,K970513
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
7be57630-6c3c-40b9-ba8b-fa935ff9d3a6
Public Version Date
September 06, 2021
Public Version Number
4
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104869
Quantity per Package
12
Contains DI Package
10841436104866
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |