Barricaid® ACD Removal Tool BAR-REMOVAL

GUDID M906BARREMOVAL0

Single-use disposable tool for removal of the Barricaid® Annular Closure Device (ACD) implant, should it be necessary to do so.

INTRINSIC THERAPEUTICS, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: M906BARREMOVAL0
• NIH Device Record Key: c90da6eb-8479-4863-b66a-bde2824c4c6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barricaid® ACD Removal Tool
• Version Model Number: 400921-A
• Catalog Number: BAR-REMOVAL
• Company DUNS: 105722131
• Company Name: INTRINSIC THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M906BARREMOVAL0 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-12
• Device Publish Date: 2020-02-04

Devices Manufactured by INTRINSIC THERAPEUTICS, INC.

• M906WED1A0 - Barricaid ACD Retraction Wedge: 2023-05-03 Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable we
• M906KITD70 - Barricaid® ACD - Reusable Instruments Kit: 2021-02-23 Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). Note
• M906DMT10X11A0 - Defect Measurement Tool (10/11mm): 2020-03-31 Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the measurement of soft tissue defects.
• M906DMT12X13A0 - Defect Measurement Tool (12/13mm): 2020-03-31 Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects.
• M906DMT4X5A0 - Defect Measurement Tool (4/5mm): 2020-03-31 Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects.
• M906DMT6X7A0 - Defect Measurement Tool (6/7mm): 2020-03-31 Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the measurement of soft tissue defects.
• M906DMT8X9A0 - Defect Measurement Tool (8/9mm): 2020-03-31 Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the measurement of soft tissue defects.
• M906EXTR1A0 - Barricaid ACD Extractor: 2020-03-31 Reusable extractor designed to facilitate Barricaid ACD removal, should it be necessary.