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Pro-Paks®️

FDA UDI

Class II (US FDA UDI)

by Microspecialities, Inc.

Identity

Trade Name
PRO-PAKS®️ FDA UDI
Generic Name
Ophthalmic surgical drape FDA UDI
Device Name
Drape Full Body N-W, SMS, Aperture and Pouches. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag. FDA UDI
Model / Reference
PD850A FDA UDI
Description
Drape Full Body N-W, SMS, Aperture and Pouches. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag. FDA UDI

Identifiers

Catalog Number
PD850A FDA UDI
Primary DI / UDI-DI
10810003220292 FDA UDI
FDA Product Code
HMT FDA UDI
GMDN Term
Ophthalmic surgical drape 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 71 Inch FDA UDI
Length — 100 Inch FDA UDI
Width — 180.34 Centimeter FDA UDI
Length — 254 Centimeter FDA UDI

Category: Ophthalmic surgical drape

Pro-Paks®️ by Microspecialities, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical drape.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microspecialities, Inc.

Sources (1)

  • FDA UDI c9de1661-5e07-4f05-ada1-79fc714780ee 36 fields · synced Jun 6, 2026