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SurgiCount Safety-Sponge

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
SurgiCount Safety-Sponge FDA UDI
Generic Name
Radiopaque woven surgical sponge, non-sterile FDA UDI
Device Name
Gauze Sponge FDA UDI
Model / Reference
0602144160 FDA UDI
Description
Gauze Sponge FDA UDI

Identifiers

Catalog Number
0602144160 FDA UDI
Primary DI / UDI-DI
07613327405279 FDA UDI
FDA Product Code
GDY FDA UDI
GMDN Term
Radiopaque woven surgical sponge, non-sterile 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 4.0 Inch FDA UDI
Length — 4.0 Inch FDA UDI

Category: Radiopaque woven surgical sponge, non-sterile

SurgiCount Safety-Sponge by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI d54165dd-25a3-4d5f-850c-1a6811b1c152 36 fields · synced Jun 8, 2026