Duns Number:006261481
Device Description: CABLE 5487 DISP 6FT STER ROHS 5PK
Catalog Number
-
Brand Name
NA
Version/Model Number
5487
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 07, 2022
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
K960446,K960446
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
60cd9ea7-00eb-430c-852f-7e9c419927a1
Public Version Date
May 05, 2022
Public Version Number
4
DI Record Publish Date
April 03, 2016
Package DI Number
20643169307333
Quantity per Package
5
Contains DI Package
00643169307339
Package Discontinue Date
February 07, 2022
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |