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Verify

FDA UDI

Class II (US FDA UDI)

by Albert Browne , Ltd.

Identity

Trade Name
VERIFY FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Chemical Indicator for SYSTEM 1E Processor FDA UDI
Model / Reference
LCC016 FDA UDI
Description
Chemical Indicator for SYSTEM 1E Processor FDA UDI

Identifiers

Catalog Number
LCC016 FDA UDI
Primary DI / UDI-DI
10724995092945 FDA UDI
510(k) Number
K102217 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Verify by Albert Browne , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b6419411-1b6e-4ca0-901a-76710c6a7df1 38 fields · synced May 30, 2026