Duns Number:147363154
Device Description: Turnstile Casting Stand® Non-fold
Catalog Number
1091-B
Brand Name
Turnstile Casting Stand®
Version/Model Number
1091-B
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
-
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
LGG
Product Code Name
Instrument, Cast Application/Removal, Manual
Public Device Record Key
d4a09429-04de-4600-8226-3fd87f4f1b70
Public Version Date
October 29, 2019
Public Version Number
1
DI Record Publish Date
October 21, 2019
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 | 518 |