Captured T10 Screwdriver, Short

GUDID 00848665033007

ADVANCED ORTHOPEDIC SOLUTIONS INC

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00848665033007
• NIH Device Record Key: 2c3fb615-813e-4001-8f60-f8a5e00aca6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Captured T10 Screwdriver, Short
• Version Model Number: 5025-200
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com
• Phone: 3105339966
• Email: regaffairs@aosortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848665033007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152732

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

[00848665033007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-20

On-Brand Devices [Captured T10 Screwdriver, Short]

• 00848665028768: 5025-100
• 00848665033007: 5025-200