Duns Number:064617010
Device Description: LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter
Catalog Number
-
Brand Name
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter
Version/Model Number
490-00189-03
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"
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
ec72a712-e8a1-41ad-82c0-6ff4209d0cd6
Public Version Date
March 18, 2021
Public Version Number
1
DI Record Publish Date
March 10, 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. | 13 |