Sdc3

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: SDC3 FDA UDI
Generic Name: Endoscopic device remote control FDA UDI
Device Name: Device Control Package FDA UDI
Model / Reference: 0240060102 FDA UDI
Description: Device Control Package FDA UDI

Identifiers

Catalog Number: 0240060102 FDA UDI
Primary DI / UDI-DI: 07613327056174 FDA UDI
510(k) Number: K160332 FDA UDI
FDA Product Code: HRX FDA UDI
GCJ FDA UDI
GMDN Term: Endoscopic device remote control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
876.1500 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: Endoscopic device remote control

Sdc3 by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic device remote control.

REMOTE CONTROL — Olympus Medical Systems Corporation · Class II
Imaging (ZEOS) — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
PENTAX — HOYA CORPORATION · Class II
ENDOCAM — Richard Wolf GmbH · Class II
DYONICS 25 — Smith & Nephew, Inc. · Class II
OBCU REMOTE CONTROLLER — Olympus Medical Systems Corporation · Class II
Trinity — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
ZEOS — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II

Cleared under the same submission

K160332 also covers:

Connect OR OS — Stryker Corp.
Connected OR OS — Stryker Corp.

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: Stryker Corp.

Sources (1)

FDA UDI 89b5b4d9-be20-4062-a89e-9683f01f8280 36 fields · synced May 30, 2026