BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Unipack

DI: D784UPST0751 · Model: UPST-075 · UNIPACK MEDICAL CORPORATION

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

8

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Basic Information

Brand Name: Unipack
Primary DI: D784UPST0751
Version / Model: UPST-075
Catalog Number: UPST-075
Company Name: UNIPACK MEDICAL CORPORATION
Labeler DUNS: 018319397
Distribution Status: In Commercial Distribution
Device Count in Pkg: 8
Record Status: Published
Publish Date: 2022-12-06
Public Version: 3
Public Version Date: 2026-04-13
Public Version Status: Update
Public Device Record Key: 206011cb-a75b-4b04-9a95-2bb7f1d462e8
Distribution End Date: 2026-12-31

Device Description

Sterilization Tape Steam 3/4" x 60 yards

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCT	Sterilization wrap containers, trays, cassettes & other accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784UPST0755	HIBCC	Case	6	In Commercial Distribution	2026-12-31
Primary	D784UPST0751	HIBCC
Unit of Use	D784UPST0750	HIBCC

Customer Contacts

Phone: +1(631)656-3800 ext. 172
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K993764	000