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A Plus

FDA UDI

Class I (US FDA UDI)

by A Plus International, Inc

Identity

Trade Name
A Plus FDA UDI
Generic Name
Radiopaque non-woven surgical sponge FDA UDI
Device Name
4"x36", 4Ply, Pre-Washed, Single Vaginal Lap Sponge with Blue Loop, X-Ray Detectable Strip, Data Matrix Label, 200 Pc(s)/Case FDA UDI
Model / Reference
1 FDA UDI
Description
4"x36", 4Ply, Pre-Washed, Single Vaginal Lap Sponge with Blue Loop, X-Ray Detectable Strip, Data Matrix Label, 200 Pc(s)/Case FDA UDI

Identifiers

Catalog Number
SV-0436-PB FDA UDI
Primary DI / UDI-DI
00683534840498 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Radiopaque non-woven surgical sponge FDA UDI

Classification

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

Clinical & Handling

Sterile

No

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

Category: Radiopaque non-woven surgical sponge

A Plus by A Plus International, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque non-woven surgical sponge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
A Plus International, Inc

Sources (1)

  • FDA UDI 853f37c8-d9a5-4522-89c0-48c66b5e030a 34 fields · synced May 31, 2026