Duns Number:021628771
Device Description: A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" long with 7/8" diameter opening. Box of 100.
Catalog Number
26100
Brand Name
Delasco Electrosurgical Handpiece Sheath
Version/Model Number
26100
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
e04d8708-b2d6-43c3-b0dd-6327cbe2559d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 15, 2016
Package DI Number
20609960000279
Quantity per Package
35
Contains DI Package
10609960000272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |