Duns Number:774856749
Catalog Number
-
Brand Name
Tissue Temp Probe
Version/Model Number
3101-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K142216,K142216,K142216
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
18dea5d7-8908-44ae-9e40-8c79b7085d2b
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 18, 2016
Package DI Number
57340007000022
Quantity per Package
10
Contains DI Package
17340007000024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |