Syntervention

Basic Information

• Brand Name: Syntervention
• Primary DI: 00850049994903
• Version / Model: 4008-305
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 017535668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-09-26
• Public Version: 1
• Public Version Date: 2025-10-06
• Public Version Status: New
• Public Device Record Key: 1b49f770-31fe-441e-bbe0-2a45f210f9b6

Device Description

SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent surgical sponge intended for use in a variety of surgical or medical procedures. SWICKER can be used in multiple surgical procedures and areas including patient prepping, open surgery, laparoscopic and robotic surgery, instrument padding, instrument cleaning, and wound care. SWICKER Radiopaque Sponge 2 Pack, 3" x 3" x .25".

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: MR Safe
• 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
Package	10850049994900	GS1	Case	200	In Commercial Distribution
Primary	00850049994903	GS1
Unit of Use	00850049993135	GS1