Endolumik

FDA UDI

Class II (US FDA UDI)

by Endolumik, Inc.

Identity

Trade Name: Endolumik FDA UDI
Generic Name: Gastric calibration tube FDA UDI
Device Name: Endolumik Gastric Calibration Tube, 40F FDA UDI
Model / Reference: EGCT40 FDA UDI
Description: Endolumik Gastric Calibration Tube, 40F FDA UDI

Identifiers

Primary DI / UDI-DI: G461EGCT400 FDA UDI
FDA Product Code: FAT FDA UDI
KNT FDA UDI
GMDN Term: Gastric calibration tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5365 FDA UDI
876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Circumference — 41.9 Millimeter FDA UDI

Category: Gastric calibration tube

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

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BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 40Fr w/bulb — BOEHRINGER LABORATORIES, LLC · Class II
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Gastric Balloon Suction Catheter — ReShape Lifesciences Inc. · Class II
GastriSail — Covidien LP · Class II
ReShape Calibration Tubes™ — ReShape Lifesciences Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Endolumik, Inc.

Sources (1)

FDA UDI cc6e1506-46b4-4a6a-a174-f2bdb439a562 36 fields · synced Jun 6, 2026