Duns Number:103977526
Device Description: Disposable non-sterile (25.4cm) standard perforated thermoplastic (3.2mm)
Catalog Number
MTAPUNB
Brand Name
Uni-frame® Thermoplastic
Version/Model Number
MTAPUNB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 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,K093738,K933227,K080072,K093738,K933227
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
0b620309-b583-4e46-9711-776dce58f69f
Public Version Date
November 01, 2019
Public Version Number
7
DI Record Publish Date
September 25, 2017
Package DI Number
00841439103791
Quantity per Package
5
Contains DI Package
10841439103798
Package Discontinue Date
November 01, 2019
Package Status
Not 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 |