AceConnex™

Basic Information

• Brand Name: AceConnex™
• Primary DI: 00810053078679
• Version / Model: PSF141100-5
• Catalog Number: PSF141100-5
• Company Name: ALLOSOURCE
• Labeler DUNS: 946808136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-08
• Public Version: 1
• Public Version Date: 2023-11-16
• Public Version Status: New
• Public Device Record Key: b7000c97-a8ba-4a95-b199-b7bddbdc54bc

Device Description

AceConne™ Pre-Sutured Fascia

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65189	Cadaveric-donor fascia allograft	An implantable device consisting of fascial tissue (fascia lata) intended for transplantation from a deceased human donor to a genetically different human recipient. It is intended to repair, replace or reinforce structural soft tissue/connective tissue to facilitate wound healing, including repair of dura, eyelid or dental defects.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810053078679	GS1

Premarket Submissions

Submission Number	Supplement Number
K213046	000

Device Sizes

Type	Value	Unit	Text
Length	100	Millimeter
Outer Diameter	5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -40 Degrees Celsius