HYGITECH - Start kitHYGITECHReference: HY-0921The START kit - HYGITECH

Duns Number:279456896

Device Description: Start kitHYGITECHReference: HY-0921The START kit is a great starter kit for light or heavy Start kitHYGITECHReference: HY-0921The START kit is a great starter kit for light or heavy implantology procedures. Each kit contains 32 separate items:4 Polyethylene gloves2 tie-on masks2 surgical hats1 Bouffant cap1 Pair of overshoes1 Patient gown with cotton cuffs2 Protective sleeves for tubing (3.5" x 47" / 8 x 120 cm)1 ice bag1 surgical drape with adhesive (39" x 39" / 100x100cm)1 surgical drape with aperture (27.5" x 31.5" / 70 x 80cm)2 Elastic cap handle covers1 saliva ejector1 non-latex elastic band1 surgical drape with adhesive (59" x 59" / 150x150cm)1 tube support with adhesive1 surgical brush with nail cleaner4 Paper hand-towels2 surgical gowns with cotton cuffs1 Wrapping paper

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More Product Details

Catalog Number

HY-0921

Brand Name

HYGITECH

Version/Model Number

HY-0921

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

f8224844-e9d7-4acf-94d8-b2165121b077

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

03615140005142

Quantity per Package

5

Contains DI Package

03615140005135

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