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SteriTec Instant Readout Class 6 Chemical Emulator Challenge Pack

FDA UDI

Class II (US FDA UDI)

by Steritec Product Mfg. Co., Inc.

Identity

Trade Name
SteriTec Instant Readout Class 6 Chemical Emulator Challenge Pack FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Model / Reference
LT 108 FDA UDI

Identifiers

Catalog Number
LT 108 FDA UDI
Primary DI / UDI-DI
00814434020233 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
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

Category: Chemical/physical sterilization process indicator

SteriTec Instant Readout Class 6 Chemical Emulator Challenge Pack by Steritec Product Mfg. Co., Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steritec Product Mfg. Co., Inc.

Sources (1)

  • FDA UDI 39e4fe60-e657-4c61-b870-5ed9a95c661f 34 fields · synced May 30, 2026