Duns Number:789127011
Device Description: DB-5: Monopolar single use pencil, 2 button; spatula electrode; L 5m (1 pc per pack, 25 p DB-5: Monopolar single use pencil, 2 button; spatula electrode; L 5m (1 pc per pack, 25 packs in a inner box, 50 packs in a master case)
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
DB-5
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
464c9088-7011-4f39-ac1d-cdd704665324
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
June 06, 2017
Package DI Number
20817120020702
Quantity per Package
2
Contains DI Package
10817120020705
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 |