Nds

FDA UDI

Class I (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: NDS FDA UDI
Generic Name: Endoscopic video image display unit FDA UDI
Device Name: ZEROWIRE G2 PAIR (RX & TX) FDA UDI
Model / Reference: NDS90T2070 FDA UDI
Description: ZEROWIRE G2 PAIR (RX & TX) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333244089 FDA UDI
FDA Product Code: KQM FDA UDI
GMDN Term: Endoscopic video image display unit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4160 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic video image display unit

Nds by PENTAX of America, Inc. — 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: PENTAX of America, Inc.

Sources (1)

FDA UDI 4d48df2e-40a0-477d-acd1-c5587803dbb0 33 fields · synced Jun 1, 2026