Duns Number:063519193
Device Description: TIDIShield Microscope Drapes Clear Polyethylene Sterile 44 IN X 120 IN for 65MM Lens 10 pe TIDIShield Microscope Drapes Clear Polyethylene Sterile 44 IN X 120 IN for 65MM Lens 10 per Case
Catalog Number
-
Brand Name
TIDIShield
Version/Model Number
441265
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EPT
Product Code Name
Microscope, Surgical
Public Device Record Key
30e603bf-d780-4675-b91b-26ab75d521e0
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
March 31, 2017
Package DI Number
00618125142484
Quantity per Package
10
Contains DI Package
01618125142483
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |