Duns Number:064617010
Device Description: LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
Catalog Number
-
Brand Name
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
Version/Model Number
490-00183-00, 490-00189-00
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"
Yes
For Single-Use
-
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
K163510
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
c480f9b3-eda4-4d81-a8e3-a5d0c81f5f7d
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 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. | 13 |