Barricaid® ACD (Annular Closure Device) BAR-A8-10MM

GUDID M906BARA810MM0

Barricaid® Annular Closure Device (ACD), 10mm width/size.

INTRINSIC THERAPEUTICS, INC.

Intervertebral disc prolapse repair implant

• Primary Device ID: M906BARA810MM0
• NIH Device Record Key: 1d3b5769-495b-476a-9920-dc98786aadc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barricaid® ACD (Annular Closure Device)
• Version Model Number: 10mm width
• Catalog Number: BAR-A8-10MM
• Company DUNS: 105722131
• Company Name: INTRINSIC THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781.932.0222
• Email: info@in-thera.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M906BARA810MM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160050

FDA Product Code

• QES: Reherniation Reduction Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-10
• Device Publish Date: 2019-05-14

On-Brand Devices [Barricaid® ACD (Annular Closure Device)]

• M906BARA810MM0: Barricaid® Annular Closure Device (ACD), 10mm width/size.
• M906BARA88MM0: Barricaid® Annular Closure Device (ACD), 8mm width