Duns Number:103977526
Device Description: (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), an (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), and Type 3 Bridge(1)
Catalog Number
MTSBRT410
Brand Name
Body Pro-Lok™ System Lite
Version/Model Number
MTSBRT410
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 04, 2022
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
K093738,K111340
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
b8bfdab4-c13b-40b1-80ec-1d02e0a53b52
Public Version Date
September 05, 2022
Public Version Number
9
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 |