Guided Surgery Key 0460GSK

GUDID D7850460GSK0

5.0mm Guided Surgery Key 1.8mm/4.6mm

OCO BIOMEDICAL INC

Surgical drill guide, reusable

• Primary Device ID: D7850460GSK0
• NIH Device Record Key: fd9e7b5b-e26f-4135-89e7-1d021f6b8c66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guided Surgery Key
• Version Model Number: 5.0mm Guided Surgery Key
• Catalog Number: 0460GSK
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7850460GSK0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

[D7850460GSK0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Guided Surgery Key]

• D785GSKINT20: Guided Surgery Key - Intermediate 2 for drill sizes 3.6mm - 4.6mm
• D785GSKINT10: Guided Surgery Key - Intermediate 1 for drill sizes 2.9mm - 3.6mm
• D7850460GSK0: 5.0mm Guided Surgery Key 1.8mm/4.6mm
• D7850360GSK0: 4.0mm Guided Surgery Key 1.8mm/3.6mm
• D7850290GSK0: 3.25mm Guided Surgery Key 1.8mm/2.9mm