Gazetex®

Basic Information

• Brand Name: Gazetex®
• Primary DI: 00809958000250
• Version / Model: 4501M
• Catalog Number: DUP4501-M
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: ab527d4c-937b-4863-bf51-fa2b14405012

Device Description

2 in diameter Gazetex prep sponge with tail. Large with twisted knot. Sterile.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
44971	General-purpose surgical sponge	A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958000250	GS1
Unit of Use	00809958000632	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.5	Inch