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Sdc4k

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
SDC4K FDA UDI
Generic Name
Operating room audiovisual data/device management system FDA UDI
Device Name
Information Management System FDA UDI
Model / Reference
0240300100 FDA UDI
Description
Information Management System FDA UDI

Identifiers

Catalog Number
0240300100 FDA UDI
Primary DI / UDI-DI
07613327562750 FDA UDI
510(k) Number
K220108 FDA UDI
FDA Product Code
GCJ FDA UDI
HRX FDA UDI
GMDN Term
Operating room audiovisual data/device management system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
888.1100 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

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Operating room audiovisual data/device management system

Sdc4k by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room audiovisual data/device management system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 8456ade8-1b8e-4f84-aaea-a7feeccb75a7 36 fields · synced Jun 8, 2026