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Attest™

FDA UDI

Class II (US FDA UDI)

by 3m Company

Identity

Trade Name
Attest™ FDA UDI
Generic Name
Biological sterilization indicator reader FDA UDI
Device Name
3M™ Attest™ Auto-Reader for Use with Super Rapid Readout Biological Indicators for Steam 490 FDA UDI
Model / Reference
490 FDA UDI
Description
3M™ Attest™ Auto-Reader for Use with Super Rapid Readout Biological Indicators for Steam 490 FDA UDI

Identifiers

Catalog Number
490 FDA UDI
Primary DI / UDI-DI
50707387763058 FDA UDI
510(k) Number
K103277 FDA UDI
FDA Product Code
FRC FDA UDI
GMDN Term
Biological sterilization indicator reader FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 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

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: Biological sterilization indicator reader

Attest™ by 3m Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biological sterilization indicator reader.

Cleared under the same submission

K103277 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA UDI 22499728-2126-41e3-86c2-7e736cb69bb7 36 fields · synced May 31, 2026