TabletVu

FDA UDI

Class II (US FDA UDI)

by Intravu, Inc.

Identity

Trade Name: TabletVu FDA UDI
Generic Name: Endoscopic video image display unit FDA UDI
Device Name: TabletVu is a reusable visualization system for use with the IntraVu Scope. FDA UDI
Model / Reference: IV-ASY-2000 FDA UDI
Description: TabletVu is a reusable visualization system for use with the IntraVu Scope. FDA UDI

Identifiers

Catalog Number: IV-ASY-2000 FDA UDI
Primary DI / UDI-DI: 00865351000389 FDA UDI
510(k) Number: K181982 FDA UDI
FDA Product Code: HRX FDA UDI
GCJ FDA UDI
GMDN Term: Endoscopic video image display unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image display unit

TabletVu by Intravu, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K181982 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: Intravu, Inc.

Sources (1)

FDA UDI e47c2a84-7436-40ae-9967-e13b4b0ff6ea 37 fields · synced May 31, 2026