HYGITECH - The IMPLANFIELD kit is designed for protecting - HYGITECH

Duns Number:279456896

Device Description: The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended fo The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surgeries that are not implantology- or endodontology-specific. Indeed, these surgeries do not usually require an operating room meaning there are more surfaces to cover. The kit is composed of 25 items:1 4 Polyethylene gloves2 1 Plastic bag (50x80cm)3 2 Adhesive films (5x80cm)4 1 Tube support with adhesive5 3 Protective sleeves for tubing (8x120cm)6 1 Adhesive protective cover for control panel7 2 Elastic cap handle covers8 1 Protective PVC X-ray cover9 2 Surgical drapes (75x75cm)10 1 Instrument table cover (90x120cm)11 1 Instrument table cover (bridge) (100x180cm)12 1 Surgical drape with aperture and adhesive (75x90cm)13 1 U-shaped surgical drape with adhesive (100x150cm)14 3 Non-latex elastic bands15 1 Wrapping paperThe IMPLANFIELD kit is complementary to the IMPLANWEAR kit, which contains all clothing protection for the operation.The materials# Polypropylene non woven fabric# Laminated non-woven fabric# SMS Microfibre# Crepe paper

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More Product Details

Catalog Number

HY-0861

Brand Name

HYGITECH

Version/Model Number

HY-0861

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

2ebc2c06-de7f-439f-a607-4017cbd77459

Public Version Date

December 15, 2020

Public Version Number

2

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

03615140002479

Quantity per Package

5

Contains DI Package

03615140002462

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