Duns Number:103021940
Device Description: PARTS LIST, TAC VITRECTOMY HANDPIECE
Catalog Number
OM0201011D
Brand Name
AMO TAC VITRECTOMY HANDPIECE
Version/Model Number
OM0201011D
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
HKP
Product Code Name
INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED
Public Device Record Key
c24d299f-d450-4653-8897-4201aa97fe4b
Public Version Date
February 26, 2020
Public Version Number
4
DI Record Publish Date
September 02, 2016
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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |