Duns Number:058614483
Device Description: Dense Tissue Shaver Mini
Catalog Number
-
Brand Name
TruClear
Version/Model Number
72204064
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
K161763,K161763
Product Code
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
2340375f-c519-4901-b637-7f2c628c39c2
Public Version Date
August 31, 2021
Public Version Number
4
DI Record Publish Date
October 16, 2017
Package DI Number
90884521744093
Quantity per Package
999
Contains DI Package
10884521744097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |