apollo

GUDID 00818614022406

apollo® Knotless Suture Anchor, Titanium, 5.5mm x 15mm

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: 00818614022406
• NIH Device Record Key: 017b88f5-5a19-4735-b807-2fe01cab706d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: apollo
• Version Model Number: 41-15520-TI
• Company DUNS: 117630237
• Company Name: Maruho Medical, 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: 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	00818614022406 [Primary]
GS1	10818614022403 [Package]; Package: Box [5 Units]; In Commercial Distribution

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [apollo]

• 00818614022130: Drill 6.5mm
• 00818614022062: Reusable Punch/Tap, 5.5mm
• 00818614022055: Reusable Punch/Tap, 4.5mm
• 10818614022359: Disposable Tap, 6.5mm
• 10818614021956: Disposable Tap, 5.5mm
• 10818614021949: Disposable Tap, 4.5mm
• 10818614020645: Disposable Surgical Punch, 5.5mm
• 10818614020638: Disposable Surgical Punch, 4.5mm
• 00818614021362: Medial Suture Anchor with Needles, PEEK
• 10818614022410: apollo® Knotless Suture Anchor, Titanium, 6.5mm x 15mm
• 00818614022406: apollo® Knotless Suture Anchor, Titanium, 5.5mm x 15mm
• 00818614022390: apollo® Knotless Suture Anchor, Titanium, 4.5mm x 15mm
• 00818614022383: apollo® Knotless Suture Anchor, PEEK, 6.5mm x 15mm
• 00818614022376: apollo® Knotless Suture Anchor, PEEK, 5.5mm x 15mm
• 00818614022369: apollo® Knotless Suture Anchor, PEEK, 4.5mm x 15mm