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Replacement clear plastic attachments Durette® III (temporals only) (10 units)

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Replacement clear plastic attachments Durette® III (temporals only) (10 units) FDA UDI
Generic Name
Epiocular radiation shield, reusable FDA UDI
Device Name
Replacement clear plastic attachments for Durette® III (temporals only) (10 units) FDA UDI
Model / Reference
21-440T FDA UDI
Description
Replacement clear plastic attachments for Durette® III (temporals only) (10 units) FDA UDI

Identifiers

Primary DI / UDI-DI
20697660002426 FDA UDI
FDA Product Code
IWS FDA UDI
GMDN Term
Epiocular radiation shield, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 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

Yes

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
Liquid Chemical FDA UDI

Category: Epiocular radiation shield, reusable

Replacement clear plastic attachments Durette® III (temporals only) (10 units) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Epiocular radiation shield, reusable.

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 8c88aab0-4050-480f-aeda-66a0e721450a 34 fields · synced May 30, 2026