Duns Number:326515533
Device Description: POWERGRIP P-COAT Electrode Insert Dissector Maryland, 45 cm with P-COA POWERGRIP P-COAT Electrode Insert Dissector Maryland, 45 cm with P-COAT insulation
Catalog Number
82408029
Brand Name
Guenter Bissinger Medizintechnik GmbH
Version/Model Number
82408029
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
-
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
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
5ff5d214-17f1-48e2-aca7-167a48e65514
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1012 |