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Jmu

FDA UDI

Class II (US FDA UDI)

by Jmu Dental, Inc

Identity

Trade Name
JMU FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Sterilizer Indicator Tape, for STEAM STERILIZATION only (yellow changes to black when steam processed), 1" x 60 yards, 36rolls/case FDA UDI
Model / Reference
32113003 FDA UDI
Description
Sterilizer Indicator Tape, for STEAM STERILIZATION only (yellow changes to black when steam processed), 1" x 60 yards, 36rolls/case FDA UDI

Identifiers

Primary DI / UDI-DI
D930321130030 FDA UDI
510(k) Number
K171823 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

Yes

FDA UDI

Category: Chemical/physical sterilization process indicator

Jmu by Jmu Dental, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K171823 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jmu Dental, Inc

Sources (1)

  • FDA UDI 838def38-ffb2-43b2-b512-8e78a08729c0 34 fields · synced Jun 7, 2026