Duns Number:809555139
Device Description: ExactEtch Restricted Depth Stab Knife, 15 Degree, 3mm Straight
Catalog Number
-
Brand Name
ExactEtch
Version/Model Number
2125K
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
d2c0a660-8908-4d21-a401-7b5a9e2ba625
Public Version Date
November 01, 2019
Public Version Number
1
DI Record Publish Date
October 24, 2019
Package DI Number
00813059010049
Quantity per Package
6
Contains DI Package
00813059010728
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 | 475 |
U | Unclassified | 13 |