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Hygitech

FDA UDI

Class I (US FDA UDI)

by Hygitech

Identity

Trade Name
HYGITECH FDA UDI
Generic Name
Denture repair kit, professional FDA UDI
Device Name
Protect Plus kit HYGITECH Reference: HY-0981 The PROTECT PLUS kit is HYGITECH's most comprehensive kit, offering a variety of products to ensure the full protection of the surgery, including drapes and clothing for the surgeon, assistant and patient. Each kit contains 58 items. 4 Polyethylene gloves 2 Tie-on masks 2 Surgical hats 3 Bouffant caps 1 Patient gown with cotton cuffs 2 Surgical gowns with cotton cuffs 1 Pair of overshoes for patient 2 Pairs of non-slip overshoes 2 Sterile brushes with nail cleaner 4 Paper hand-towels 2 Saliva ejectors 3 Adhesive protective covers for control panel 1 Protective PVC X-ray cover 2 Adhesive films (2" x 31.5" / 5x80cm) 1 Chair cover with 6 ties 4 Protective sleeves for tubing (3.5" x 47" / 8 x 120cm) 3 Non-latex elastic bands 2 Elastic cap handle covers 1 Tube support with adhesive 1 Surgical drape (59" x 59" / 150x150cm) with adhesive 1 Absorbent drape (59" x 59" / 150x150cm) with adhesive 2 Surgical drapes (39" x 39" / 100x100 cm) with adhesive 1 Surgical drape with aperture and adhesive (27.5" x 31.5" / 70x80cm) 1 Surgical drape with aperture (27.5" x 31.5" / 70x80cm) 2 Ice bags 1 Plastic bag (20" x 31.5" / 50x80cm) 1 Wrapping paper FDA UDI
Model / Reference
HY-0981 FDA UDI
Description
Protect Plus kit HYGITECH Reference: HY-0981 The PROTECT PLUS kit is HYGITECH's most comprehensive kit, offering a variety of products to ensure the full protection of the surgery, including drapes and clothing for the surgeon, assistant and patient. Each kit contains 58 items. 4 Polyethylene gloves 2 Tie-on masks 2 Surgical hats 3 Bouffant caps 1 Patient gown with cotton cuffs 2 Surgical gowns with cotton cuffs 1 Pair of overshoes for patient 2 Pairs of non-slip overshoes 2 Sterile brushes with nail cleaner 4 Paper hand-towels 2 Saliva ejectors 3 Adhesive protective covers for control panel 1 Protective PVC X-ray cover 2 Adhesive films (2" x 31.5" / 5x80cm) 1 Chair cover with 6 ties 4 Protective sleeves for tubing (3.5" x 47" / 8 x 120cm) 3 Non-latex elastic bands 2 Elastic cap handle covers 1 Tube support with adhesive 1 Surgical drape (59" x 59" / 150x150cm) with adhesive 1 Absorbent drape (59" x 59" / 150x150cm) with adhesive 2 Surgical drapes (39" x 39" / 100x100 cm) with adhesive 1 Surgical drape with aperture and adhesive (27.5" x 31.5" / 70x80cm) 1 Surgical drape with aperture (27.5" x 31.5" / 70x80cm) 2 Ice bags 1 Plastic bag (20" x 31.5" / 50x80cm) 1 Wrapping paper FDA UDI

Identifiers

Catalog Number
HY-0981 FDA UDI
Primary DI / UDI-DI
03615140005159 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Denture repair kit, professional FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Denture repair kit, professional

Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture repair kit, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hygitech

Sources (1)

  • FDA UDI dea799ad-1d6b-4c71-8608-d861060c7650 34 fields · synced Jun 6, 2026