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Crosstex International

FDA UDI

Class II (US FDA UDI)

by Steritec Product Mfg. Co., Inc.

Identity

Trade Name
Crosstex International FDA UDI
Generic Name
Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
Device Name
Sure Check Strip FDA UDI
Model / Reference
SCK FDA UDI
Description
Sure Check Strip FDA UDI

Identifiers

Catalog Number
SCK FDA UDI
Primary DI / UDI-DI
10732224109265 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Surgical/medical respirator, non-antimicrobial, single-use 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

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

Yes

FDA UDI

Category: Surgical/medical respirator, non-antimicrobial, single-use

Crosstex International by Steritec Product Mfg. Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical respirator, non-antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9b65100b-edf9-43d7-b042-ea22a02715f1 35 fields · synced May 29, 2026