Duns Number:103977526
Device Description: IMRT Clear Vision 2 open face thermoplastic (3.2mm)
Catalog Number
PRO331IM1832S
Brand Name
ProForm™ Thermoplastic
Version/Model Number
PRO331IM1832S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K180021,K180021
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
410da1ed-d4a3-44c1-a3ec-c14789762a9f
Public Version Date
August 11, 2022
Public Version Number
3
DI Record Publish Date
May 22, 2021
Package DI Number
10841439113476
Quantity per Package
5
Contains DI Package
00841439113479
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |