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Esi

FDA UDI

Class II (US FDA UDI)

by Ftt Medical, Inc.

Identity

Trade Name
ESI FDA UDI
Generic Name
Visible-light skin transilluminator FDA UDI
Device Name
ESI STRAIGHT TRANSILLUMINATOR, 1/4" DIAMETER, ACMI FITTING. FDA UDI
Model / Reference
05-0102 FDA UDI
Description
ESI STRAIGHT TRANSILLUMINATOR, 1/4" DIAMETER, ACMI FITTING. FDA UDI

Identifiers

Primary DI / UDI-DI
B3960501020 FDA UDI
FDA Product Code
HJM FDA UDI
GMDN Term
Visible-light skin transilluminator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1945 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Visible-light skin transilluminator

Esi by Ftt Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visible-light skin transilluminator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ftt Medical, Inc.

Sources (1)

  • FDA UDI 2542e45f-4471-4268-983a-c1cc30ba3e18 33 fields · synced Jun 1, 2026