ORHTOMED

GUDID B8035100780

ISRAEL RETRACTOR 9 1/2" 3 PRONGS

ORTHO-MED, INC.

Hand-held surgical retractor, reusable

• Primary Device ID: B8035100780
• NIH Device Record Key: a415712a-a2cc-4c05-9e78-3a13d0a06465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORHTOMED
• Version Model Number: OM 51-0078
• Company DUNS: 086618626
• Company Name: ORTHO-MED, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B8035100780 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

[B8035100780]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

Devices Manufactured by ORTHO-MED, INC.

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• B8035504990 - ORTHOMED: 2026-02-05 MISKIMON CEREB.RETR. 7 1/2" 7X7 SH
• B8037203000 - ORTHOMED: 2026-02-05 BONE PIN WITH THREE FLUTES 3.5" ROUND
• B8037203050 - ORTHOMED: 2026-02-05 BONE PIN W/3-FULTES 3.2MM DIA. 63MM OVERALL LENGTH
• B8038601050 - ORTHOMED: 2026-02-05 CAPSULE RETRACTOR TWO PRONG 10"
• B8038601150 - ORTHOMED: 2026-02-05 RIGHT ANGLED HOHMANN RETRACTOR 10 1/4"
• B8038601200 - ORTHOMED: 2026-02-05 RIGHT ANGLED HOHMANN RETRACTOR 9 3/4"