Syntervention

GUDID 10850049994986

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, instrument padding, instrument cleaning, and wound care. SWICKER DIGIT is an over-the-finger configuration of the SWICKER product family. SWICKER DIGIT is designed to be used over a gloved finger. SWICKER Radiopaque Digit 1Pk

ZIEN MEDICAL TECHNOLOGIES, INC.

Radiopaque non-woven surgical sponge

• Primary Device ID: 10850049994986
• NIH Device Record Key: b65800dc-7aa2-465f-a05a-1695b035c875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntervention
• Version Model Number: 4011
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049994989 [Primary]
GS1	10850049994986 [Package]; Contains: 00850049994989; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• GDY: Gauze/Sponge, Internal, X-Ray Detectable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Syntervention ]

• 10850049994986: SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent
• 10850049994993: SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent
• 10858303003047: SWASHER Ultra Low-Lint Surgical Towel. 4 Pack, Blue
• 10858303003030: SWASHER Ultra Low-Lint Surgical Towel. 2 Pack, Blue
• 10858303003016: SWIPER Medical Device Foam Wiper 2 Pack.
• 10858303003009: SWIPER Medical Device Foam Wiper 1 Pack