Duns Number:789127011
Device Description: BM2526 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 25mm length, 0.45mm(26G) D BM2526 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 25mm length, 0.45mm(26G) Diameter
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
BM2526 (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
b38a2b1a-3c4d-4629-8329-1d85dbadf54f
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2017
Package DI Number
20817120020894
Quantity per Package
8
Contains DI Package
10817120020897
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 |