Medical Action Industries

FDA UDI

Class I (US FDA UDI)

by Medical Action Industries Inc.

Identity

Trade Name: Medical Action Industries FDA UDI
Generic Name: Radiopaque woven surgical sponge FDA UDI
Device Name: Sponge: Speciality Kittner Diss 500/cs FDA UDI
Model / Reference: B7102 FDA UDI
Description: Sponge: Speciality Kittner Diss 500/cs FDA UDI

Identifiers

Primary DI / UDI-DI: 20809160021832 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: Radiopaque 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Radiopaque woven surgical sponge

Medical Action Industries by Medical Action Industries Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge.

SurgiCount Safety-Sponge — Stryker Corp. · Class I
DuLap® — Derma Sciences Canada, Inc · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
ORLocate — STERIS CORPORATION · Class I
Kerlix — Cardinalhealth · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
AMD-RITMED — AMD Medicom Inc · Class I
Dukal — Dukal LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medical Action Industries Inc.

Sources (1)

FDA UDI 8baf24e8-a76c-4d8b-81d8-3bcc2f138208 34 fields · synced May 30, 2026