Duns Number:174262477
Device Description: CUSTOM SURGICAL KIT X-LG GOWN/TOWEL
Catalog Number
-
Brand Name
STRADIS
Version/Model Number
SS79888
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 21, 2022
Issuing Agency
In HIBCC
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
LRO
Product Code Name
General Surgery Tray (Kit)
Public Device Record Key
d230aba4-81b1-4cf8-87ae-ed770ed9c335
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
June 15, 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 | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |