Duns Number:015272206
Device Description: Pisacano nucleus rotator, 4 1/2'', angled shaft, 10.5mm from bend to tip, flat, blunt, dis Pisacano nucleus rotator, 4 1/2'', angled shaft, 10.5mm from bend to tip, flat, blunt, disc-shaped horizontal tip, round handle
Catalog Number
9219E
Brand Name
Ambler Surgical
Version/Model Number
Pisacano nucleus rotator
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
HNQ
Product Code Name
Hook, ophthalmic
Public Device Record Key
f217e0f1-8288-430a-8a7f-53751c6b7b19
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
January 07, 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 |