Duns Number:789127011
Device Description: BE1227P-15T (Lifelines) - Lifelines OEM, Twisted EP Needle, Pairs - 150cm Leadwire, 12mm l BE1227P-15T (Lifelines) - Lifelines OEM, Twisted EP Needle, Pairs - 150cm Leadwire, 12mm length, 0.40mm diameter
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
BE1227P-15T (Lifelines)
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
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
d37d7745-fe13-4139-96ef-0fe54001d53d
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
December 07, 2017
Package DI Number
20817120021334
Quantity per Package
8
Contains DI Package
10817120021337
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 103 |