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Operon

FDA UDI

Class I (US FDA UDI)

by Berchtold Holding GmbH

Identity

Trade Name
Operon FDA UDI
Generic Name
Universal operating table, electrohydraulic FDA UDI
Device Name
Berchtold Surgical Table, D 820 FDA UDI
Model / Reference
OT 8204514 FDA UDI
Description
Berchtold Surgical Table, D 820 FDA UDI

Identifiers

Catalog Number
OT 8204514 FDA UDI
Primary DI / UDI-DI
07613327412604 FDA UDI
FDA Product Code
GDC FDA UDI
GMDN Term
Universal operating table, electrohydraulic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Operon by Berchtold Holding GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 6a009ab3-8c62-44ba-9b2c-35bd39fd5ee2 36 fields · synced May 30, 2026