Duns Number:009452895
Device Description: mi-probe. surigcal instrument for soft tissue manipulation during mi-eye procedure
Catalog Number
T900-015
Brand Name
mi-probe
Version/Model Number
T900-011
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
HXB
Product Code Name
Probe
Public Device Record Key
1f4133f0-39a4-4a9e-b9bd-10c21fc58264
Public Version Date
May 11, 2018
Public Version Number
1
DI Record Publish Date
April 10, 2018
Package DI Number
00861578000393
Quantity per Package
5
Contains DI Package
00861578000386
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |