Duns Number:017663522
Device Description: 1 Funnel Assembly, 1 Plunger Assembly, 2 Raps
Catalog Number
9066-00
Brand Name
PERPOS FUSION Facet Prep Kit
Version/Model Number
9066-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 23, 2016
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
9d82c3b4-3a9b-4ced-8eca-1c03e2570168
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2015
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 | 150 |
2 | A medical device with a moderate to high risk that requires special controls. | 132 |
U | Unclassified | 13 |