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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
The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary conditions.It is easy to put on and fix. FDA UDI
Model / Reference
HY-139 FDA UDI
Description
The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary conditions.It is easy to put on and fix. FDA UDI

Identifiers

Catalog Number
HY-139 FDA UDI
Primary DI / UDI-DI
03615140002431 FDA UDI
FDA Product Code
FXP FDA UDI
GMDN Term
Denture repair kit, professional FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 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 5fe4e5ce-6bc6-4109-9e83-21cc37de053a 34 fields · synced Jun 1, 2026