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Specwell

FDA UDI

Class I (US FDA UDI)

by Specwell Corporation

Identity

Trade Name
SPECWELL FDA UDI
Generic Name
Indirect monocular ophthalmoscope, electrically-powered FDA UDI
Model / Reference
2x 8 FDA UDI

Identifiers

Primary DI / UDI-DI
04582697820018 FDA UDI
FDA Product Code
HKB FDA UDI
GMDN Term
Indirect monocular ophthalmoscope, electrically-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.5870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Indirect monocular ophthalmoscope, electrically-powered

Specwell by Specwell Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indirect monocular ophthalmoscope, electrically-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Specwell Corporation

Sources (1)

  • FDA UDI 58a6a4e3-81e2-45b0-aeab-2097e35706ee 32 fields · synced May 30, 2026