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SwitchPoint Infinity, iSuite

FDA UDI

Class II (US FDA UDI)

by STRYKER Communications, Inc.

Identity

Trade Name
SwitchPoint Infinity, iSuite FDA UDI
Generic Name
Operating room audiovisual data/device management system FDA UDI
Device Name
Infinity 3, Video Router FDA UDI
Model / Reference
0678001000 FDA UDI
Description
Infinity 3, Video Router FDA UDI

Identifiers

Catalog Number
0678-001-000 FDA UDI
Primary DI / UDI-DI
07613327054156 FDA UDI
510(k) Number
K100852 FDA UDI
FDA Product Code
OCS 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
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

SwitchPoint Infinity, iSuite by STRYKER Communications, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K100852 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
STRYKER Communications, Inc.

Sources (1)

  • FDA UDI f21afdc0-67dc-4b75-9e53-372d4439e0e0 36 fields · synced May 29, 2026