Duns Number:021628771
Device Description: These needle adapters allow you to attach a metal hub needle to any electrosurgical unit. These needle adapters allow you to attach a metal hub needle to any electrosurgical unit. The adapters have a 3/32" (2.4mm) diameter shaft size, which fits most electrosurgical units.ADAPT/6 has a shaft (1 3/8") which was designed specifically for the Delasco 734/1134 and Aaron/Bovie handpieces. This will fit most other electrosurgical units as well but may stick out of the handpiece slightly longer. Luer lock connection, reusable and convenient. Accepts metal hub, Luer Lock needles.This device is subject to direct marking, but excepted due to technological infeasibility.
Catalog Number
ADAPT/6
Brand Name
Delasco ADAPT/6 Needle Adapter
Version/Model Number
ADAPT/6
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
-
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
K001029
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
56e5af0c-61af-473f-a07b-ef6087d5706b
Public Version Date
August 29, 2018
Public Version Number
3
DI Record Publish Date
June 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |