Barricaid ACD Sizing Trial (10mm) ST-10-A

GUDID M906ST10A0

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

INTRINSIC THERAPEUTICS, INC.

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Primary Device IDM906ST10A0
NIH Device Record Key3bf2eee3-ba14-4c97-851c-8eed1f480850
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBarricaid ACD Sizing Trial (10mm)
Version Model Number400877
Catalog NumberST-10-A
Company DUNS105722131
Company NameINTRINSIC THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com
Phone781.932.0222
Emailinfo@in-thera.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM906ST10A0 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


[M906ST10A0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-31
Device Publish Date2019-05-14

Devices Manufactured by INTRINSIC THERAPEUTICS, INC.

M906WED1A0 - Barricaid ACD Retraction Wedge2023-05-03 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 Kit2021-02-23 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 Extractor2020-03-31 Reusable extractor designed to facilitate Barricaid ACD removal, should it be necessary.

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