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DuCare®

FDA UDI

Class I (US FDA UDI)

by Derma Sciences Canada, Inc

Identity

Trade Name
DuCare® FDA UDI
Generic Name
Radiopaque woven surgical sponge FDA UDI
Device Name
1.25 in Single Strugn Tonsil Sponge. X-Ray detectable FDA UDI
Model / Reference
3053 FDA UDI
Description
1.25 in Single Strugn Tonsil Sponge. X-Ray detectable FDA UDI

Identifiers

Catalog Number
DUP3053 FDA UDI
Primary DI / UDI-DI
00809958030912 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiopaque woven surgical sponge

DuCare® by Derma Sciences Canada, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Derma Sciences Canada, Inc

Sources (1)

  • FDA UDI b8deb6c5-cd12-48f3-9a32-79e739744cd1 36 fields · synced May 30, 2026