HYGITECH - Duo kitHYGITECHReference: HY-09011The DUO kit is - HYGITECH

Duns Number:279456896

Device Description: Duo kitHYGITECHReference: HY-09011The DUO kit is the kit needed for dressing both the surg Duo kitHYGITECHReference: HY-09011The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items.4 Polyethylene gloves1 surgical drape (29.5"x 29.5"/ 75x75cm)2 Elastic cap handle covers2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm)3 non-latex elastic bands1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm)1 surgical cap2 Bouffant caps2 tie-on masks2 Pairs of overshoes1 surgical brush with nail cleaner4 Paper hand-towels1 assistant gown with cotton cuffs1 surgical gown with cotton cuffs1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm)1 Wrapping paper

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More Product Details

Catalog Number

HY-09011

Brand Name

HYGITECH

Version/Model Number

HY-09011

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

d2b0ad4d-5c72-4372-9471-4a21a2123a34

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

03615140005302

Quantity per Package

5

Contains DI Package

03615140005296

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