SWICKER

Basic Information

• Brand Name: SWICKER
• Primary DI: 00850049993753
• Version / Model: 4008-309
• Catalog Number: 4008-309
• Company Name: Syntervention, Inc.
• Labeler DUNS: 025315999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-11-09
• Public Version: 1
• Public Version Date: 2023-11-17
• Public Version Status: New
• Public Device Record Key: 4758b1e0-905e-4af5-8337-71a9ed70b2cd

Device Description

The SWICKER is a sterile, highly absorbent medical accessory product intended for use in variety of surgical or medical procedures. Comprised primarily of a form of polyurethane, it has many uses including in areas such as open surgery, laparoscopic surgery, and wound care.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
39404	Radiopaque non-woven surgical sponge	A non-medicated 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850049993173	GS1
Primary	00850049993753	GS1

Device Sizes

Type	Value	Unit	Text
Length	9	Inch
Width	9	Inch
Height	0.25	Inch