Apollo Medial with needles

GUDID 00818614021355

Apollo Medial with needles

Maruho Medical, Inc.

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00818614021355
• NIH Device Record Key: 927e66b8-a1c1-4d48-b91b-bbb65004a00f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Medial with needles
• Version Model Number: 27-11145
• Company DUNS: 117630237
• Company Name: Maruho Medical, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00818614021355 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

Devices Manufactured by Maruho Medical, Inc.

• 00818614022635 - ABS Med Distraction Pin: 2023-09-06 ABS Med Distraction Pin , 12MM Pouch
• 10818614022649 - ABS Med Distraction Pin: 2023-09-06 ABS Med Distraction Pin, 14MM Patient (Inner)
• 10818614021406 - Distraction Screw: 2023-06-02 Distraction Screw, 12MM Patient (Inner)
• 10818614021413 - Distraction Screw: 2023-06-02 Distraction Screw, 14MM Patient (Inner)
• 10818614022601 - Distraction Pin, 12MM pouch: 2023-06-02 Sharp Distraction Pin, 12MM pouch
• 10818614022618 - Distraction Pin, 14MM pouch: 2023-06-02 Sharp Distraction Pin, 14MM pouch
• 00818614021355 - Apollo Medial with needles: 2022-09-09Apollo Medial with needles
• 00818614021355 - Apollo Medial with needles: 2022-09-09 Apollo Medial with needles
• 00818614022550 - Distraction Screw, 12MM Pouch: 2022-09-09 Synergy Distraction Screw, 12MM Pouch