Duns Number:008018525
Device Description: ClearCut® Slit Knife Intrepid micro-coaxial system 2.0 SB
Catalog Number
-
Brand Name
ClearCut®; Intrepid
Version/Model Number
8065992045
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
HNN
Product Code Name
Knife, ophthalmic
Public Device Record Key
4e695be7-6bb1-43bd-8fa3-92f2cbc264bd
Public Version Date
August 26, 2020
Public Version Number
1
DI Record Publish Date
August 18, 2020
Package DI Number
10380659920452
Quantity per Package
6
Contains DI Package
00380659920455
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 | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |