Duns Number:071595540
Device Description: HYPERFLEX GUIDEWIRE, NITINOL, 9 IN, STERILE, 1.6 X 229MM (.062 X 9IN)
Catalog Number
8571D
Brand Name
HYPERFLEX
Version/Model Number
8571D
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
-
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
a9719129-f4dc-40a6-8f89-379dae7150f9
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
20845854041618
Quantity per Package
5
Contains DI Package
10845854041611
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |