Duns Number:081057389
Device Description: HALYARD* Surgical Cap-3-Layer SMS on Sides, Spunbond on Top
Catalog Number
69520
Brand Name
Halyard
Version/Model Number
69520
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"
Yes
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
FYF
Product Code Name
CAP, SURGICAL
Public Device Record Key
a10699a5-55fc-4a59-9e3a-d92f1b7988b0
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
November 16, 2020
Package DI Number
30680651695209
Quantity per Package
3
Contains DI Package
20680651695202
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 |