MediClear™ PreOp

FDA UDI

Class II (US FDA UDI)

by Covalontechnologies, Inc.

Identity

Trade Name: MediClear™ PreOp FDA UDI
Generic Name: Patient surgical drape, single-use FDA UDI
Device Name: Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Silver FDA UDI
Model / Reference: 7000607 FDA UDI
Description: Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Silver FDA UDI

Identifiers

Primary DI / UDI-DI: 00825439012871 FDA UDI
510(k) Number: K163556 FDA UDI
FDA Product Code: KKX 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Patient surgical drape, single-use

MediClear™ PreOp by Covalontechnologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Patient surgical drape, single-use.

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PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLC · Class II
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Cleared under the same submission

K163556 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Covalontechnologies, Inc.

Sources (1)

FDA UDI f5ec0d15-e53d-42a7-8845-6ca57bf3bee0 35 fields · synced May 30, 2026