HYGITECH - Non-Woven bouffant capIntermediate protection :- - HYGITECH

Duns Number:279456896

Device Description: Non-Woven bouffant capIntermediate protection :- It holds back loose hair from the face- I Non-Woven bouffant capIntermediate protection :- It holds back loose hair from the face- Ideal for people with long hair.

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More Product Details

Catalog Number

HY-50015

Brand Name

HYGITECH

Version/Model Number

HY-50015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FYF

Product Code Name

Cap, Surgical

Device Record Status

Public Device Record Key

4022d8fe-8cc6-4d56-a138-e4be57cdecfe

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

03615140003278

Quantity per Package

10

Contains DI Package

03615140003261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"HYGITECH" Characteristics
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