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Silent Scan

FDA UDI

Class II (US FDA UDI)

by Avotec, Inc.

Identity

Trade Name
Silent Scan FDA UDI
Generic Name
Patient audiovisual communication/entertainment system FDA UDI
Device Name
Complete Silent Scan 3200 system FDA UDI
Model / Reference
3200 FDA UDI
Description
Complete Silent Scan 3200 system FDA UDI

Identifiers

Primary DI / UDI-DI
00850010651101 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Patient audiovisual communication/entertainment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient audiovisual communication/entertainment system

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

Similar devices

Also classified as Patient audiovisual communication/entertainment system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avotec, Inc.

Sources (1)

  • FDA UDI f96c6e16-0872-43b0-9c73-d031fb5f4677 34 fields · synced May 30, 2026