Duns Number:202659140
Device Description: The Laparoscopic Insulation Tester checks the integrity of the insulation on laparoscopic The Laparoscopic Insulation Tester checks the integrity of the insulation on laparoscopic instruments. This unit is intended to verify insulation integrity on laparoscopic instruments.
Catalog Number
PR701480
Brand Name
NA
Version/Model Number
PR701480
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2020
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
-
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
K120416
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
d10bdc38-7061-4c58-942a-16503a7675e6
Public Version Date
June 24, 2020
Public Version Number
7
DI Record Publish Date
September 13, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |