Dermapac, Inc.

Basic Information

• Brand Name: Dermapac, Inc.
• Primary DI: 10810102270433
• Version / Model: 5371
• Company Name: Dermapac Inc.
• Labeler DUNS: 796088466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 125
• Record Status: Published
• Publish Date: 2022-09-12
• Public Version: 1
• Public Version Date: 2022-09-20
• Public Version Status: New
• Public Device Record Key: 545a3531-8b7f-4e57-a465-354f76e449f9

Device Description

Danbury Rounds (OR gauze sponges 5/pk 2pks/pouch)

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: 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: No
• 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
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., 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, it may also be used for prepping the patient. It 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810102270436	GS1
Primary	10810102270433	GS1

Customer Contacts

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