Catalog Number
OSM0077
Brand Name
Rexious
Version/Model Number
A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K111362
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
cb692536-4726-420f-8a57-8f2e18a2a335
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 07, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7203 |
U | Unclassified | 227 |