HYGITECH - Protect Extend kitReference: HY-0991The HYGITECH - HYGITECH

Duns Number:279456896

Device Description: Protect Extend kitReference: HY-0991The HYGITECH Protect Extend kit responds to all needs Protect Extend kitReference: HY-0991The HYGITECH Protect Extend kit responds to all needs of implant surgery. We’ve now added to our best seller HYGITECH Protect kit 3 essential elements for implant surgery :-A universal irrigation set-An aspiration set with tube and yankauer cannula-A 2,5mm cannula and adaptorThe kit is composed of 49 items:1 4 Polyethylene gloves2 2 Tie-on masks3 1 Surgical hat4 2 Bouffant caps5 1 Surgical gown with cotton cuffs6 1 Assistant gown with cotton cuffs7 1 Patient gown with cotton cuffs8 3 Pairs of overshoes9 2 Sterile brushes with nail cleaner10 6 Paper hand-towels11 1 Surgical drape (75x75cm)1 Instrument table cover (bridge) (90x120cm)1 U-shaped surgical drape with adhesive (100x150cm)1 Surgical drape with aperture and adhesive (70x100cm)2 Protective sleeves for tubing (8cmx120cm)3 Non-latex elastic bands1 Adhesive film (5cmx80cm)2 Elastic cap handle covers2 Adhesive protective covers for control panel1 Tube support with adhesive1 Protective PVC X-ray cover1 universal irrigation set1 2,5mm cannula with adaptor1 aspiration set with cannula1 Wrapping paper

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More Product Details

Catalog Number

HY-0991

Brand Name

HYGITECH

Version/Model Number

HY-0991

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

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Device Record Status

Public Device Record Key

a9c1321c-b8cf-4d9c-95ad-f98374d85f1d

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

03615140005180

Quantity per Package

5

Contains DI Package

03615140005173

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