JGRKNT NEEDLES 2.9MM INLINE GD SSI007594

GUDID 00889024679528

Biomet Orthopedics, LLC

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00889024679528
• NIH Device Record Key: 667c9f67-9844-42e7-9e24-d601e05b205f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JGRKNT NEEDLES 2.9MM INLINE GD
• Version Model Number: SSI007594
• Catalog Number: SSI007594
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024679528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150768

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

[00889024679528]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-21
• Device Publish Date: 2025-01-13

Devices Manufactured by Biomet Orthopedics, LLC

• 00889024679528 - JGRKNT NEEDLES 2.9MM INLINE GD: 2025-01-21
• 00889024679528 - JGRKNT NEEDLES 2.9MM INLINE GD: 2025-01-21
• 00889024684317 - Juggerknot Reusable Fishmouth Guide: 2025-01-21
• 00889024685604 - Jgrknt Reusable Fishmouth Curved Perc Guide: 2025-01-21
• 00887868254451 - Comprehensive® Reverse Shoulder: 2024-11-21
• 00887868578250 - Comprehensive®: 2024-11-13
• 08428898885684 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11