HYGITECH - The PROTECT kit is HYGITECH’s best selling kit, - HYGITECH

Duns Number:279456896

Device Description: The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of implant surgery.The kit is composed of 45 items:4 Polyethylene gloves1 Instrument table cover (bridge) (90x120cm)1 Surgical drape (75x75cm)2 Protective sleeves for tubing (8cmx120cm)1 Tube support with adhesive2 Elastic cap handle covers1 Protective PVC X-ray cover2 Adhesive protective covers for control panel3 Non-latex elastic bands1 Adhesive film 5x80cm1 Surgical hat2 Bouffant caps2 Tie-on masks3 Pairs of overshoes2 Sterile brushes with nail cleaner6 Paper hand-towels1 Surgical gown with cotton cuffs1 Assistant gown with cotton cuffs1 Patient gown with cotton cuffs1 Surgical drape with aperture and adhesive (70x100cm)1 U-shaped surgical drape with adhesive (100x150cm)1 impermeable wrapping paper

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More Product Details

Catalog Number

HY-0871

Brand Name

HYGITECH

Version/Model Number

HY-0871

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

29bc11a7-5f11-4970-a2d6-d79dcb4f5215

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

December 14, 2020

Additional Identifiers

Package DI Number

03615140005265

Quantity per Package

5

Contains DI Package

03615140005258

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