Syntervention

FDA UDI

Class I (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: Syntervention FDA UDI
Generic Name: Radiopaque non-woven surgical sponge FDA UDI
Device Name: 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 FDA UDI
Model / Reference: 4011 FDA UDI
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, 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850049994989 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: Radiopaque non-woven surgical sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiopaque non-woven surgical sponge

Syntervention by ZIEN Medical Technologies, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI b65800dc-7aa2-465f-a05a-1695b035c875 33 fields · synced May 30, 2026