Duns Number:109903521
Device Description: REFLECTION CONSTRAINED LINER 0 DEGREE 32MM INNER DIAMET REFLECTION CONSTRAINED LINER 0 DEGREE 32MM INNER DIAMETER 66-68MM OUTER DIAMETER SIZE J
Catalog Number
71323138
Brand Name
REFLECTION
Version/Model Number
71323138
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Yes
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
K033442
Product Code
KWZ
Product Code Name
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Public Device Record Key
aae2621d-effd-438d-8aba-03a0885281eb
Public Version Date
December 21, 2020
Public Version Number
8
DI Record Publish Date
August 30, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |