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.

• B8035102140 - ORTHOMED: 2025-07-04 RICH. EASTMAN RETR. 10 1/4" LARGE
• B8035102160 - ORTHOMED: 2025-07-04 KELLY RETR. 9 3/4" 1 1/2" X 2"
• B8035102180 - ORTHOMED: 2025-07-04 KELLY RETR. 9 3/4" 2" X 2 1/2"
• B8035102200 - ORTHOMED: 2025-07-04 KELLY RETR. 9 3/4" 2 1/2" X 3"
• B8035102220 - ORTHOMED: 2025-07-04 KELLY RETR. 9 3/4" 3" X 3 1/2"
• B8035102120 - ORTHOMED: 2025-07-03 RICH. EASTMAN RETR. 9 1/2" SMALL
• B8037104623 - ORTHOMED: 2025-06-26 STEIN.PIN DBL.TROCAR 9" 9/64" 3.5MM
• B8037104653 - ORTHOMED: 2025-06-26 STEIN.PIN DBL.TROCAR 9" 5/32" 4.0MM