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Sgp Ii

FDA UDI

Class II (US FDA UDI)

by Lifestyle Co Inc, The

Identity

Trade Name
SGP II FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, Gray, or Clear Number of Units FDA UDI
Model / Reference
telefocon B FDA UDI
Description
Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, Gray, or Clear Number of Units FDA UDI

Identifiers

Primary DI / UDI-DI
00830002002012 FDA UDI
PMA Number
P840055 FDA UDI
FDA Product Code
HQD 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

Sgp Ii by Lifestyle Co Inc, The — 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

P840055 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lifestyle Co Inc, The

Sources (1)

  • FDA UDI 38c68841-4d30-40be-ab18-0ae2e54a54b9 35 fields · synced Jun 8, 2026