Barricaid® ACD - Reusable Instruments Kit (Tray Only)

Basic Information

• Brand Name: Barricaid® ACD - Reusable Instruments Kit (Tray Only)
• Primary DI: M906KITD4C10
• Version / Model: 400885
• Catalog Number: KIT-D4-C1
• Company Name: INTRINSIC THERAPEUTICS, INC.
• Labeler DUNS: 105722131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-04
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: e21fc8c9-3568-4874-a032-1d678283da29

Device Description

Empty tray to hold kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). This is an empty tray, instruments provided separately. Note that the implant itself, as well as the delivery tool to which the implant is pre-loaded, are single-use sterile and supplied separately.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

GMDN Terms

Code	Name	Definition	Implantable	Status
13180	Orthopaedic prosthesis implantation positioning instrument, reusable	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M906KITD4C10	HIBCC

Customer Contacts

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