INTRINSIC THERAPEUTICS, INC.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Reherniation Reduction Device (QES) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Barricaid® ACD (Annular Closure Device) - M906BARA810MM0 Catalog Number : BAR-A8-10MM

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

Device Class : 3

Duns Number: 105722131

Premarket Exempt : No

Product Code : QES

Prescription Use : Yes

Device Count : 1

Barricaid® ACD (Annular Closure Device) - M906BARA88MM0 Catalog Number : BAR-A8-8MM

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

Device Class : 3

Duns Number: 105722131

Premarket Exempt : No

Product Code : QES

Prescription Use : Yes

Device Count : 1

Barricaid® ACD Alignment Trial (10mm) - M906BARAT100 Catalog Number : BAR-AT-10

Device Description : Alignment and 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

Barricaid® ACD Alignment Trial (8mm) - M906BARAT80 Catalog Number : BAR-AT-8

Device Description : Alignment and sizing trial (8mm size) used to assist with implantation of the Ba Alignment and sizing 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

Defect Measurement Tool (10/11mm) - M906BARDMT10X110 Catalog Number : BAR-DMT-10X11

Device Description : Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the me Stainless steel rod with specific sized ends (10 and 11 mm) for aiding in the measurement of soft tissue defects.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Defect Measurement Tool (12/13mm) - M906BARDMT12X130 Catalog Number : BAR-DMT-12X13

Device Description : Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the me Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Defect Measurement Tool (4/5mm) - M906BARDMT4X50 Catalog Number : BAR-DMT-4X5

Device Description : Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the meas Stainless steel rod with specific sized ends (4 and 5 mm) for aiding in the measurement of soft tissue defects.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Defect Measurement Tool (6/7mm) - M906BARDMT6X70 Catalog Number : BAR-DMT-6X7

Device Description : Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the meas Stainless steel rod with specific sized ends (6 and 7 mm) for aiding in the measurement of soft tissue defects.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Defect Measurement Tool (8/9mm) - M906BARDMT8X90 Catalog Number : BAR-DMT-8X9

Device Description : Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the meas Stainless steel rod with specific sized ends (8 and 9 mm) for aiding in the measurement of soft tissue defects.

Device Class :

Duns Number: 105722131

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Barricaid® ACD Impactor - M906BARIMPACTOR0 Catalog Number : BAR-IMPACTOR

Device Description : Single-use disposable surgical instrument to aid in insertion of the Barricaid® Single-use disposable surgical instrument to aid in insertion of the Barricaid® Annular Closure Device (ACD), in the event that additional impaction is necessary.

Device Class : 1

Duns Number: 105722131

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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