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

GUDID 00848657076043

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.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Suturing needle holder, reusable

• Primary Device ID: 00848657076043
• NIH Device Record Key: 4eab36de-d711-47bc-9beb-6931d09627a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm
• Version Model Number: ETH1592-RN
• Catalog Number: ETH1592-RN
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657076043 [Primary]

FDA Product Code

• FHQ: Holder, Needle, Gastroenterologic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

[00848657076043]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-26
• Device Publish Date: 2023-05-18

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• 00848657069236 - AED: 2026-02-02 AED Flexible Biopsy Grasper, 0.9mm x 45cm, D/A
• 00848657069243 - AED: 2026-02-02 AED Flexible Biopsy Punch, 5FR x 30cm, S/A
• 00848657069250 - AED: 2026-02-02 AED Flexible Biopsy Grasper, 5Fr x 30cm, D/A
• 00848657069618 - AED: 2026-02-02 AED Flexible Scissor Forcep, 5FR x 47cm, S/A
• 00848657074889 - AED: 2026-02-02 AED Flexible Scissor Forcep, 5Fr x 40cm, S/A