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Copioumed

FDA UDI

Class II (US FDA UDI)

by Copioumed International Inc.

Identity

Trade Name
Copioumed FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Device Name
Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site. FDA UDI
Model / Reference
SDS0B101-1 FDA UDI
Description
Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site. FDA UDI

Identifiers

Primary DI / UDI-DI
04719882250897 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Patient surgical drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Patient surgical drape, single-use

Copioumed by Copioumed International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Copioumed International Inc.

Sources (1)

  • FDA UDI ced2d5ea-4da1-4d4f-bf18-5729431f4e92 34 fields · synced Jun 8, 2026