TVC Controller Sterile Barrier

FDA UDI

Class II (US FDA UDI)

by Infraredx, Inc.

Identity

Trade Name: TVC Controller Sterile Barrier FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller FDA UDI
Model / Reference: TVC-MC8-B1 FDA UDI
Description: Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller FDA UDI

Identifiers

Catalog Number: TVC-MC8-B1 FDA UDI
Primary DI / UDI-DI: 00857595006005 FDA UDI
510(k) Number: K141682 FDA UDI
FDA Product Code: IYO FDA UDI
OGZ FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
870.1200 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

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

FDA UDI

Dimensions & Sizes

Size: Length — 96 Inch FDA UDI

Category: Medical equipment/instrument drape, single-use

TVC Controller Sterile Barrier by Infraredx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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MICROTEK — Microtek Medical LLC · Class II
Plasdent — PLASDENT CORP. · Class II
Probe Cover — Advance Medical Designs, Inc. · Class II

Cleared under the same submission

K141682 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: Infraredx, Inc.

Sources (1)

FDA UDI 0dfb2aec-2c42-434a-9e48-d6ba2b426478 38 fields · synced May 31, 2026