Duns Number:439770017
Device Description: HTC (high temperature cautery) F7277model is a sterile bipolar battery operated disposable HTC (high temperature cautery) F7277model is a sterile bipolar battery operated disposable device for the cauterization of small vessels. The fine tip length 125mm permits the accurate and effective cauterization of very small vessels. Tip reaches a maximum working temperature of 1.200°C (2.200 °F) The cautery is suitable to be used all the times a quick and precise cauterization is necessary even in difficult access sites
Catalog Number
F7277
Brand Name
NA
Version/Model Number
F7277
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
K100333,K100333
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
4b593512-02e5-49d3-805d-a2871ca0a9bb
Public Version Date
May 22, 2020
Public Version Number
1
DI Record Publish Date
May 14, 2020
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. | 42 |