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Unipack

FDA UDI

Class I (US FDA UDI)

by Unipack Medical Corporation

Identity

Trade Name
Unipack FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
X-Ray Sensor Sheaths Schick Size 2 FDA UDI
Model / Reference
UBC-820825 FDA UDI
Description
X-Ray Sensor Sheaths Schick Size 2 FDA UDI

Identifiers

Catalog Number
UBC-820825 FDA UDI
Primary DI / UDI-DI
D784UBC8208251 FDA UDI
FDA Product Code
NRD FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

No

FDA UDI

Over-the-Counter

Yes

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: Medical equipment/instrument drape, single-use

Unipack by Unipack Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment/instrument drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3b59ee78-1f24-4231-b6a4-8f9085b4695d 35 fields · synced May 31, 2026