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Unipack

FDA UDI

Class II (US FDA UDI)

by Unipack Medical Corporation

Identity

Trade Name
Unipack FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Sterilization Tape Steam 3/4" x 60 yards FDA UDI
Model / Reference
UPST-075 FDA UDI
Description
Sterilization Tape Steam 3/4" x 60 yards FDA UDI

Identifiers

Catalog Number
UPST-075 FDA UDI
Primary DI / UDI-DI
D784UPST0751 FDA UDI
510(k) Number
K993764 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 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

Yes

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

Unipack by Unipack Medical Corporation — 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

K993764 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unipack Medical Corporation

Sources (1)

  • FDA UDI 206011cb-a75b-4b04-9a95-2bb7f1d462e8 36 fields · synced May 30, 2026