INTRINSIC THERAPEUTICS, INC.

Address:30 Commerce Way,Woburn,MA,01801,US

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- Catalog Number : IMP-1-A

Device Description : Reusable impactor designed to further advance the Barricaid Anular Closure Devic Reusable impactor designed to further advance the Barricaid Anular Closure Device (ACD) anchor into the vertebral body, if during the implantation the satisfactory depth has not been achieved and the Barricaid delivery tool has already been removed.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : KIT-D4

Device Description : Kit of reusable surgical instruments to support the surgical implantation of the Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). 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 Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

- Catalog Number : KIT-D4-C1

Device Description : Empty tray to hold kit of reusable surgical instruments to support the surgical 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 Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

- Catalog Number : KIT-D7

Device Description : Kit of reusable surgical instruments to support the surgical implantation of the Kit of reusable surgical instruments to support the surgical implantation of the Barricaid® Annular Closure Device (ACD). 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 Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : NRR-SCTN

Device Description : Hand-held reusable surgical retractor for use in spinal surgery with a built-in Hand-held reusable surgical retractor for use in spinal surgery with a built-in connector to accept a suction hose.

Device Class : 1

Duns Number: 105722131

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

- Catalog Number : ST-10-A

Device Description : Sizing trial (10mm size) used to support implantation of the Barricaid ACD.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : ST-8-A

Device Description : Sizing/alignment trial (8mm size) used to assist with implantation of the Barricaid ACD.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : WED-1-A

Device Description : Wedge to aid in retraction of the delivery tool following implantation of the Ba Wedge to aid in retraction of the delivery tool following implantation of the Barricaid Anular Closure Device (ACD). Reusable wedge designed to help pull back the strike cap following full Barricaid deployment.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1