Primary Device ID | M906WED1A0 |
NIH Device Record Key | 5c5aa3e8-e376-4695-a75a-2dd8b49c774b |
Commercial Distribution Discontinuation | 2020-03-31 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Barricaid ACD Retraction Wedge |
Version Model Number | 400846 |
Catalog Number | WED-1-A |
Company DUNS | 105722131 |
Company Name | INTRINSIC THERAPEUTICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M906WED1A0 [Primary] |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
[M906WED1A0]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2023-05-03 |
Device Publish Date | 2019-05-14 |
M906WED1A0 - Barricaid ACD Retraction Wedge | 2023-05-03Wedge 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. |
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. |