Duns Number:317502326
Device Description: Sterile disposable cover for OT50001/OT90001, 74 x 120 cm (1 pouch)
Catalog Number
STEA-OT5
Brand Name
NA
Version/Model Number
STEA-OT5
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
6abb66bc-8406-41ac-9eb3-ef4b8b8a1663
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 05, 2017
Package DI Number
04251339900059
Quantity per Package
50
Contains DI Package
04251339900066
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |