Duns Number:063519193
Device Description: DRAPE FOR ZEISS RESIGHT, FULL BODY, 42" x 82" (106.7cm x 208.3 cm)
Catalog Number
-
Brand Name
Thea Surgical
Version/Model Number
31507
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)
Yes
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
343e319d-9b43-460f-a667-f49228b88856
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
January 24, 2017
Package DI Number
00618125177905
Quantity per Package
2
Contains DI Package
01618125177904
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 |