Duns Number:789127011
Device Description: SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hy SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel. 4 pcs per pack, 100 pcs per box, 1,000 pcs per case
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
SG15R (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"
Yes
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
K153019,K153019,K153019
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
f3a1cf88-f4b6-457a-b334-07e521600b3f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2017
Package DI Number
20817120021082
Quantity per Package
10
Contains DI Package
10817120021085
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 |