Elite

FDA UDI

Class I (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: ELITE FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: ELITE Needle Holder, Curved Left, 5mm, 45cm FDA UDI
Model / Reference: ETH1593-45 FDA UDI
Description: ELITE Needle Holder, Curved Left, 5mm, 45cm FDA UDI

Identifiers

Primary DI / UDI-DI: 00848657070140 FDA UDI
FDA Product Code: NWV FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.1720 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, reusable

Elite by National Advanced Endoscopy Devices, 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: National Advanced Endoscopy Devices, Inc.

Sources (1)

FDA UDI 38b6966e-c40d-4c45-b6ff-5ebf82d1228d 33 fields · synced May 31, 2026