Duns Number:789127011
Device Description: 9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad, Horizont 9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad, Horizontal (5 pcs/pouch, 40 pouches in Master Case)
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
9551F
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
K073360,K073360
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
2d25066c-f6a7-423c-b8cb-a7845c8b77fc
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
June 05, 2017
Package DI Number
10817120020736
Quantity per Package
40
Contains DI Package
00817120020739
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 |