OptiFix Absorbable Fixation System

Basic Information

• Brand Name: OptiFix Absorbable Fixation System
• Primary DI: 00801741074318
• Version / Model: 0113126
• Catalog Number: 0113126
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-16
• Public Version: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 701eb6ef-f382-48d3-95b2-a8b989d651e5

Device Description

OptiFix Absorbable Fixation System 39cm x 5mm Cannula, 30 Absorbable Fasteners

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
GDW	STAPLE, IMPLANTABLE	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45027	Soft-tissue/mesh anchor, bioabsorbable	A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741074315	GS1	CA	5	In Commercial Distribution
Primary	00801741074318	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5	Millimeter
Length	39	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 33 – 77 Degrees Fahrenheit