Barricaid® ACD (Annular Closure Device)

Basic Information

• Brand Name: Barricaid® ACD (Annular Closure Device)
• Primary DI: M906BARA88MM0
• Version / Model: 8mm width
• Catalog Number: BAR-A8-8MM
• Company Name: INTRINSIC THERAPEUTICS, INC.
• Labeler DUNS: 105722131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-14
• Public Version: 4
• Public Version Date: 2022-01-10
• Public Version Status: Update
• Public Device Record Key: 90841f30-f7da-4eb4-b3f4-ac71084bad20

Device Description

Barricaid® Annular Closure Device (ACD), 8mm width/size

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: MR Conditional
• 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: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QES	Reherniation Reduction Device	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64194	Intervertebral disc prolapse repair implant	An implantable device intended to treat a prolapsed lumbar intervertebral disc by repairing the defect in the annulus fibrosus for the prevention of recurrent herniation of the nucleus pulposus. It consists of a mesh plug used to replace the disrupted segment of the annulus, and an attached anchor used to stabilize the plug by fixation to the adjacent vertebral body. It is made of polymer and metallic materials and implanted during a posterior approach procedure. Disposable devices associated with deployment (e.g., pusher, sheath) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M906BARA88MM0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160050	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 60 Degrees Celsius