HYGITECH - The 90cm Hygitech protective sleeve efficiently - HYGITECH

Duns Number:279456896

Device Description: The 90cm Hygitech protective sleeve efficiently protects all tubing while guaranteeing the The 90cm Hygitech protective sleeve efficiently protects all tubing while guaranteeing the sterility of the operating room.These PVC single-use sleeves were specifically created with dental surgeons in mind.Characterisitics/Properties :- The sleeve’s dimensions allow the protection of tubing 90cm in length and 8,5cm in width- The sleeves contain an adhesive which giving good grip on the tubing- The box contains 250 sleevesInpermeable surface protection- Effective barrier for non-autoclavable equiptment in order to combat cross-contamination- Protection against bacteria and viruses which limits the use of disinfectants and prolongs the lifespan of equiptmentStrength- Rip ResistantEasy to use- Thanks to the adhesive at the end of the sleeves

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More Product Details

Catalog Number

HY-066

Brand Name

HYGITECH

Version/Model Number

HY-066

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

FXP

Product Code Name

Cover, Shoe, Operating-Room

Device Record Status

Public Device Record Key

a758dc19-bfa9-4327-9b2b-5f61048356d3

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

03615140002905

Quantity per Package

6

Contains DI Package

03615140002899

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