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Esi

FDA UDI

Class II (US FDA UDI)

by Ftt Medical, Inc.

Identity

Trade Name
ESI FDA UDI
Generic Name
Rigid optical sigmoidoscope, reusable FDA UDI
Device Name
YEOMAN SIGMOIDOSCOPE, 7/8" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WINDOW AND FIBEROPTIC LIGHT ASSEMBLY. ACMI FITTING. FDA UDI
Model / Reference
15-0154 FDA UDI
Description
YEOMAN SIGMOIDOSCOPE, 7/8" DIAMETER, SPECIFY WORKING LENGTH WITH DILATING WINDOW AND FIBEROPTIC LIGHT ASSEMBLY. ACMI FITTING. FDA UDI

Identifiers

Primary DI / UDI-DI
B3961501540 FDA UDI
FDA Product Code
GCF FDA UDI
GMDN Term
Rigid optical sigmoidoscope, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Rigid optical sigmoidoscope, reusable

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

Similar devices

Also classified as Rigid optical sigmoidoscope, reusable.

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 c542bc16-481b-4649-a1ed-7760e2a874e4 33 fields · synced Jun 8, 2026