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

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.

• B8035101000 - ORTHOMED: 2025-05-02 LANGENBECK RETRACTOR 3/8"X1 1/4"
• B8035101040 - ORTHOMED: 2025-05-02 LANGENBECK RETRACTOR 3/8"X1 1/2"
• B8035101080 - ORTHOMED: 2025-05-02 LANGENBECK RETRACTOR 1/2"X1 1/2"
• B8035101120 - ORTHOMED: 2025-05-02 LANGENBECK RETRACTOR 5/8"X1 1/2"
• B8035101580 - ORTHOMED: 2025-05-02 MEYERDING RETR. 9" SMALL 17X55MM
• B8035101620 - ORTHOMED: 2025-05-02 MEYERDING RETR. 9" MEDIUM 25X70MM
• B8035101640 - ORTHOMED: 2025-05-02 MEYERDING RETR. 9" LARGE 50X94MM
• B8035102000 - ORTHOMED: 2025-05-02 RICHARDSON RETR.9 1/2" 3/4" X 1"