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Enucleation/Evisceration Sizer

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Enucleation/Evisceration Sizer FDA UDI
Generic Name
Orbital sphere implant sizer FDA UDI
Device Name
Enucleation/Evisceration Sizer FDA UDI
Model / Reference
A1-020 FDA UDI
Description
Enucleation/Evisceration Sizer FDA UDI

Identifiers

Primary DI / UDI-DI
10697660005505 FDA UDI
FDA Product Code
FTY FDA UDI
GMDN Term
Orbital sphere implant sizer 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 20 Millimeter FDA UDI

Category: Orbital sphere implant sizer

Enucleation/Evisceration Sizer by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orbital sphere implant sizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (1)

  • FDA UDI 3a7283dc-4d6a-4bdb-8738-f6922e816d5a 35 fields · synced Jun 8, 2026