Dealmed

Basic Information

• Brand Name: Dealmed
• Primary DI: 00859140003767
• Version / Model: 783144
• Catalog Number: 783144
• Company Name: DEALMED MEDICAL SUPPLIES LLC
• Labeler DUNS: 068586441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-12-04
• Public Version: 1
• Public Version Date: 2020-12-14
• Public Version Status: New
• Public Device Record Key: 756eac1c-6707-4143-8792-9ac7d7b9057a

Device Description

Gauze Sponge All-Purpose Non-Woven Sterile 4" x 4" 4-Ply 2', 25/Bx

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
58803	Radiopaque non-woven surgical sponge, non-sterile	A non-medicated non-sterile device made from a non-woven absorbent material (e.g., rayon/polyester) 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, it may also be used for prepping the patient. It is intended to produce less lint than woven gauze and contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10859140003764	GS1	CASE	24	In Commercial Distribution
Primary	00859140003767	GS1
Unit of Use	00859140003552	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4" x 4"