Duns Number:006261481
Device Description: CABLE 5487L DISP 12FT STER ROHS 5PK
Catalog Number
-
Brand Name
NA
Version/Model Number
5487L
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
K960446,K960446
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
b6150bf9-8b35-42a9-982b-1c6f6c20223e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2016
Package DI Number
20643169307357
Quantity per Package
5
Contains DI Package
00643169307353
Package Discontinue Date
-
Package Status
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 |