RetroTech PULLFOR00

GUDID 03760304680564

Complete RetroTech instrumentation set intended to be used for arthroscopic implantation of the PULLUP device for ACL reconstruction.

S.B.M

Arthroscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03760304680564
• NIH Device Record Key: 678c80e1-aab7-4421-ba6a-641e5dca7526
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroTech
• Version Model Number: Complete RetroTech instrumentation set
• Catalog Number: PULLFOR00
• Company DUNS: 772462123
• Company Name: S.B.M
• 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
GS1	03760304680564 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

[03760304680564]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

On-Brand Devices [RetroTech]

• 03760304680069: RetroTech® Ø 4.7 mm cannulated drill bit to be used for retrograde drilling of bone tunnels.
• 03760304680588: RetroTech cleaning and sterilization basket.
• 03760304680052: Ring for RetroTech® retrograde drill.
• 03760304680045: RetroTech® retrograde drill bit
• 03760304680564: Complete RetroTech instrumentation set intended to be used for arthroscopic implantation of the
• 03760304681103: drill guide to be used with the RetroTech retrograde drill.