Indigo™

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Indigo™ FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: INSTRUMENT TRAY 1845040 INDIGO FDA UDI
Model / Reference: 1845040 FDA UDI
Description: INSTRUMENT TRAY 1845040 INDIGO FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000172091 FDA UDI
510(k) Number: K150728 FDA UDI
FDA Product Code: HBE FDA UDI
ERL FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4310 FDA UDI
874.4250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Instrument tray, reusable

Indigo™ by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K150728 also covers:

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: Medtronic Xomed, Inc.

Sources (1)

FDA UDI f1cb1a7c-75d5-4088-82a1-40ad98e91fb9 35 fields · synced May 30, 2026