Duns Number:789127011
Device Description: 9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouch 9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouches in Master Case) (Do Not Use)
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
9552F
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,K073360
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
4f1cfd4d-9c2d-4cb0-bb5e-8819ff01d1eb
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
June 28, 2016
Package DI Number
20817120020290
Quantity per Package
2
Contains DI Package
10817120020293
Package Discontinue Date
June 06, 2017
Package Status
Not 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 |