Duns Number:051437143
Device Description: Disposable High-Temperature (2000° C) Loop Tip Cautery battery operated with batteries ins Disposable High-Temperature (2000° C) Loop Tip Cautery battery operated with batteries installed. Unit has a four year shelf life.
Catalog Number
20-HM-1000
Brand Name
HOTSY
Version/Model Number
Cautery High Temperature Loop Tip
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
-
Product Code
HQP
Product Code Name
Unit, Cautery, Thermal, Battery-Powered
Public Device Record Key
60b9f310-831a-4de8-a8c2-379665fe01a3
Public Version Date
November 01, 2021
Public Version Number
4
DI Record Publish Date
August 12, 2016
Package DI Number
10893398002544
Quantity per Package
10
Contains DI Package
00893398002547
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 567 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |