HYGITECH - Sterile transparent drape with - HYGITECH

Duns Number:279456896

Device Description: Sterile transparent drape with adhesiveHYGITECHReference: HY-05902Practical for all surger Sterile transparent drape with adhesiveHYGITECHReference: HY-05902Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme.More infoCharacteristics :• 1 waterproof layer of polyethylene (65g/m²)• Dimensions: 40 (width) cm x 50 (length) cm• Adhesive: Located along the width of the drape(40 x 5 cm)Waterproof protection of surfaces-Effective barrier to fight against cross contaminations in non autoclavable elements.- Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longerSolidity- Resistant, does not tear

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More Product Details

Catalog Number

HY-05902

Brand Name

HYGITECH

Version/Model Number

HY-05902

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

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

00603291-5546-4da1-a990-34bcfb7d85f2

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Additional Identifiers

Package DI Number

03615140003872

Quantity per Package

25

Contains DI Package

03615140003865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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