Apollo

Basic Information

• Brand Name: Apollo
• Primary DI: B048LA6520TI0
• Version / Model: 01
• Company Name: Maruho Medical, Inc.
• Labeler DUNS: 117630237
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 6
• Public Version Date: 2021-04-08
• Public Version Status: Update
• Public Device Record Key: a0738560-3955-4973-bf94-b3cc25366ef7
• Distribution End Date: 2021-01-01

Device Description

Apollo Lateral Suture Anchor Delivery System, PEEK Screw, Titanium Punch, 6.5 x 20mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B048LA6520TI0	HIBCC
Package	B048LA6520TI1	HIBCC	Box	5	Not in Commercial Distribution	2021-01-01