Duns Number:103977526
Device Description: 45.7 x 55.9cm solid thermoplastic (2.4mm)
Catalog Number
MTHFX18222.4S
Brand Name
HipFix® Thermoplastic
Version/Model Number
MTHFX18222.4S
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
K080072,K093738,K933227,K080072,K093738,K933227
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
62b50ada-566e-4c41-b65f-9eac304905ea
Public Version Date
August 03, 2020
Public Version Number
7
DI Record Publish Date
September 25, 2017
Package DI Number
00841439104316
Quantity per Package
5
Contains DI Package
10841439104313
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 |