Duns Number:081057389
Device Description: HALYARD* I.V. Therapy HAND-AID* Arterial Wrist Support, Adult
Catalog Number
29980
Brand Name
Halyard
Version/Model Number
29980
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILH
Product Code Name
SPLINT, HAND, AND COMPONENTS
Public Device Record Key
ebee77a4-cc60-4a13-95b1-6730abe7b12f
Public Version Date
November 26, 2020
Public Version Number
1
DI Record Publish Date
November 18, 2020
Package DI Number
30680651299803
Quantity per Package
2
Contains DI Package
20680651299806
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |