Cover Multipad

FDA UDI

Class I (US FDA UDI)

by Pearl Technology AG

Identity

Trade Name: Cover Multipad FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging. FDA UDI
Model / Reference: Cover Multipad FDA UDI
Description: Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging. FDA UDI

Identifiers

Catalog Number: 1101 FDA UDI
Primary DI / UDI-DI: 07640178060067 FDA UDI
FDA Product Code: KME FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Medical equipment/instrument drape, single-use

Cover Multipad by Pearl Technology AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pearl Technology AG

Sources (1)

FDA UDI f59896b1-943e-402d-a213-9bd2f6e07f18 35 fields · synced Jun 8, 2026