Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784UNW30331
• Version / Model: UNW-3033
• Catalog Number: UNW-3033
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 3
• Public Version Date: 2024-11-07
• Public Version Status: Update
• Public Device Record Key: dbf758d9-7e62-444c-aaa4-3a9e2e2de546
• Distribution End Date: 2024-06-27

Device Description

Non-Woven Sponges 3" x 3", Non-Sterile

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784UNW30335	HIBCC	Case	20	Not in Commercial Distribution	2024-06-27
Primary	D784UNW30331	HIBCC
Unit of Use	D784UNW30330	HIBCC

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]