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INTRABEAM SMART Spherical Applicator (40mm)

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
INTRABEAM SMART Spherical Applicator (40mm) FDA UDI
Generic Name
Nucleic acid microarray probe chip IVD FDA UDI
Model / Reference
309120-9040-000 FDA UDI

Identifiers

Primary DI / UDI-DI
04049539105561 FDA UDI
510(k) Number
K241174 FDA UDI
FDA Product Code
JAD FDA UDI
GMDN Term
Nucleic acid microarray probe chip IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nucleic acid microarray probe chip IVD

INTRABEAM SMART Spherical Applicator (40mm) by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K241174 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI 20a620e5-2dfa-4200-a625-ffc6d5c8a728 33 fields · synced May 30, 2026