Duns Number:103977526
Device Description: Reusable Panorama 50cm overlay with Prodigy Lok-Bar, supports (4), risers (4), adhesive, a Reusable Panorama 50cm overlay with Prodigy Lok-Bar, supports (4), risers (4), adhesive, abrasive paper, button location fixtures
Catalog Number
MTM3402
Brand Name
IPPS Overlay
Version/Model Number
MTM3402
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2019
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
-
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
K080072
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
5e4cc9b6-634c-46c1-af51-532bd6e1ca8d
Public Version Date
August 29, 2019
Public Version Number
5
DI Record Publish Date
August 02, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |