Duns Number:834612764
Device Description: SpineJet® Percutaneous Access Curved Set-Disposable
Catalog Number
56987
Brand Name
SpineJet®
Version/Model Number
56987
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
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
K002764
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
ea7f4ab7-0c9c-48f3-9684-1eb150b2a821
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 21, 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. | 32 |