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Hexa100

FDA UDI

Class II (US FDA UDI)

by Contamac Holdings Limited

Identity

Trade Name
HEXA100 FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Rigid Gas Permeable Contact Lens FDA UDI
Model / Reference
hexafocon A FDA UDI
Description
Rigid Gas Permeable Contact Lens FDA UDI

Identifiers

Catalog Number
hexafocon A FDA UDI
Primary DI / UDI-DI
00865576000287 FDA UDI
510(k) Number
K180616 FDA UDI
FDA Product Code
HQD FDA UDI
MUW FDA UDI
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5916 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rigid-gas-permeable corrective contact lens, daily-wear

Hexa100 by Contamac Holdings Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, daily-wear.

Cleared under the same submission

K180616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Contamac Holdings Limited

Sources (1)

  • FDA UDI d000cfe7-2aaa-484a-ade9-0c88f35b3faa 35 fields · synced May 29, 2026