Plak-Vac

FDA UDI

Class I (US FDA UDI)

by Trademark Medical, L.l.c.

Identity

Trade Name: Plak-Vac FDA UDI
Generic Name: Oral care kit, single-use FDA UDI
Device Name: Plak-Vac custom kit FDA UDI
Model / Reference: 3107 FDA UDI
Description: Plak-Vac custom kit FDA UDI

Identifiers

Catalog Number: 3107 FDA UDI
Primary DI / UDI-DI: B23931070 FDA UDI
FDA Product Code: NXZ FDA UDI
GMDN Term: Oral care kit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6855 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Oral care kit, single-use

Here is a concise, professional 2-sentence SEO-friendly product description for the medical device 'Plak-Vac':

"The Plak-Vac custom kit provides a comprehensive oral care solution with various devices and supplies tailored to individual patient needs, improving oral hygiene and reducing infection risk." Customizable kits are designed for hospitals and institutions, allowing staff to apply the device in accordance with established protocols.

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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: Trademark Medical, L.l.c.

Sources (1)

FDA UDI d4bf82ba-ad11-4fa6-a514-470d7a79085c 34 fields · synced Jun 19, 2026