Duns Number:557799209
Device Description: The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction o The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
Catalog Number
-
Brand Name
GUARDIAN-SG Inflatable Bone Expander System
Version/Model Number
2BMK(T)15αS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143006
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
1b10e82e-871e-4c6b-9647-9606cecbcc9d
Public Version Date
May 06, 2020
Public Version Number
6
DI Record Publish Date
June 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. | 149 |