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Non-Woven IV Sponge

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Non-Woven IV Sponge FDA UDI
Generic Name
Non-woven gauze pad FDA UDI
Device Name
Non-Woven IV Sponge, 2"x2", 6-ply, Sterile, 2'ss. FDA UDI
Model / Reference
4610 FDA UDI
Description
Non-Woven IV Sponge, 2"x2", 6-ply, Sterile, 2'ss. FDA UDI

Identifiers

Primary DI / UDI-DI
00616784461014 FDA UDI
FDA Product Code
NAB FDA UDI
FRL FDA UDI
GMDN Term
Non-woven gauze pad FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 FDA UDI
880.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Non-woven gauze pad

Non-Woven IV Sponge by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-woven gauze pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI 6d169186-9731-4a06-b45b-d066b1f1dd1a 33 fields · synced May 30, 2026