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Esi

FDA UDI

Class II (US FDA UDI)

by Ftt Medical, Inc.

Identity

Trade Name
ESI FDA UDI
Generic Name
Optical proctoscope, reusable FDA UDI
Device Name
CUSTOM 12CM PROCTOSCOPE, INSULATED. FDA UDI
Model / Reference
MSK081209 FDA UDI
Description
CUSTOM 12CM PROCTOSCOPE, INSULATED. FDA UDI

Identifiers

Primary DI / UDI-DI
B396MSK0812090 FDA UDI
FDA Product Code
GCF FDA UDI
GMDN Term
Optical proctoscope, 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: Optical proctoscope, reusable

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

Similar devices

Also classified as Optical proctoscope, 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 78688650-656e-4cd3-99f5-6a25ccd32e8a 33 fields · synced May 31, 2026