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Steam Indicator Tape

EUDAMEDFDA UDI

Class I (EU MDR)

Ref STLF24MMModel Chemical Indicators

by Crosstex International Inc

Identity

Trade Name
Steam Indicator Tape EUDAMEDFDA UDI
Generic Name
Sterilization packaging, single-use FDA UDI
Device Name
Lead Free, 1 in x 60 yd (24 mm x 55 mm) FDA UDI
Model / Reference
Chemical Indicators EUDAMED
STLF24MM EUDAMEDFDA UDI
Description
Lead Free, 1 in x 60 yd (24 mm x 55 mm) FDA UDI

Identifiers

Catalog Number
STLF24MM FDA UDI
Primary DI / UDI-DI
00732224004129 EUDAMEDFDA UDI
Basic UDI-DI
0732224ChemIndicator6N EUDAMED
510(k) Number
K191741 FDA UDI
FDA Product Code
JOJ FDA UDI
EMDN Code
S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
GMDN Term
Sterilization packaging, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Steam Indicator Tape by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
US-MF-000009642
Authorised Representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Sources (2)

  • EUDAMED f3981ac2-23b9-43f9-a72b-b1eadf9b199e 61 fields · synced Jun 18, 2026
  • FDA UDI b1013f6f-c5ce-4619-8439-e40df9e4409c 37 fields · synced May 29, 2026