Phasix™ ST Mesh with Echo 2™ Positioning System

Basic Information

• Brand Name: Phasix™ ST Mesh with Echo 2™ Positioning System
• Primary DI: 00801741161223
• Version / Model: 1210015
• Catalog Number: 1210015
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-12
• Public Version: 1
• Public Version Date: 2019-07-22
• Public Version Status: New
• Public Device Record Key: 89390361-06da-484a-9cf6-6c7949749d32

Device Description

Phasix™ ST with Echo 2™ Positioning System, Circle

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
OWT	Mesh, surgical, absorbable, abdominal hernia	General, Plastic Surgery	878.3300	2
ORQ	Mesh, surgical, deployer	General, Plastic Surgery	878.3300	2
OOD	surgical film	General, Plastic Surgery	878.3300	2
FTL	Mesh, surgical, polymeric	General, Plastic Surgery	878.3300	2
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63946	Abdominal hernia surgical mesh, synthetic polymer, bioabsorbable	A sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of bioabsorbable synthetic polymer(s) intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer, positioner, trocar) may be included.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741161223	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	15	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius