Duns Number:279456896
Device Description: Astronaut capHYGITECHReference: HY-50018Ultimate protection: - Recommended for long or hig Astronaut capHYGITECHReference: HY-50018Ultimate protection: - Recommended for long or high-risk surgeries- It holds back loose hair and is ideal for medium to long hair- Fixes with 2 non-woven ties for the best protection and comfort- Only the face remains uncovered, head, neck and ears are protected
Catalog Number
HY-50018
Brand Name
HYGITECH
Version/Model Number
HY-50018
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
c40c29d3-89d1-4f20-8fa3-7e3e03fab24b
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140003575
Quantity per Package
10
Contains DI Package
03615140003568
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 | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |