AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm

FDA UDI

Class I (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. FDA UDI
Model / Reference: ETH1592-RN FDA UDI
Description: A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. FDA UDI

Identifiers

Catalog Number: ETH1592-RN FDA UDI
Primary DI / UDI-DI: 00848657076043 FDA UDI
FDA Product Code: FHQ FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, reusable

AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm by National Advanced Endoscopy Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID

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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 4eab36de-d711-47bc-9beb-6931d09627a7 35 fields · synced May 30, 2026