Duns Number:015272206
Device Description: LRI economy triple-edge diamond knife, straight, 1.00mm wide, 0.20mm truncated tip, sharp LRI economy triple-edge diamond knife, straight, 1.00mm wide, 0.20mm truncated tip, sharp sides, single footplate, preset at 550 microns, short j-slot aluminum handle
Catalog Number
21-239E
Brand Name
Ambler Surgical
Version/Model Number
LRI economy triple-edge diamond knife
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
-
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
acefdd36-5177-413d-8d8e-6a50b12453ae
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14984 |
2 | A medical device with a moderate to high risk that requires special controls. | 3118 |