Post-Op Sponges

Basic Information

• Brand Name: Post-Op Sponges
• Primary DI: 00616784334905
• Version / Model: 3349
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-28
• Public Version: 1
• Public Version Date: 2022-05-06
• Public Version Status: New
• Public Device Record Key: d7c5d494-5ef7-4a3a-943e-cc00e859de86

Device Description

Post-Op Sponges, Non-Woven, Sterile, 4" x 4", 4-Ply (10.2cm x 10.2cm)

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
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	00616784334905	GS1
Package	00616784334912	GS1	Pouch	2	In Commercial Distribution
Package	00616784334929	GS1	Box	25	In Commercial Distribution
Package	00616784334936	GS1	Case	24	In Commercial Distribution