Duns Number:789127011
Device Description: LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ i LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ in a case
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
LWSBR48(N)
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
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
3b9393e9-e941-414c-87a5-0d13a50a8769
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 05, 2016
Package DI Number
10817120020453
Quantity per Package
250
Contains DI Package
00817120020456
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 103 |