| Primary Device ID | 10858733006021 |
| NIH Device Record Key | 81650f1f-056d-482b-bf73-452b15458d03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MI CUFF - Aortic Root Exposure Device |
| Version Model Number | 4.0 |
| Catalog Number | MI-CUFF-001 |
| Company DUNS | 073724333 |
| Company Name | Biorep Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858733006024 [Primary] |
| GS1 | 10858733006021 [Package] Contains: 00858733006024 Package: Shelf Box [6 Units] In Commercial Distribution |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
[10858733006021]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-01 |
| Device Publish Date | 2024-04-23 |
| 00861361000241 - Irrigation Syringe Attachment | 2025-02-24 The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device |
| 10858733006007 - JOSEPH LAMELAS Knot Pusher | 2024-05-01 The JOSEPH LAMELAS Knot Pusher is a disposable surgical instrument used to advance throws of extracorporeal knots to an intracor |
| 10858733006014 - JOSEPH LAMELAS Atrial Lift System | 2024-05-01 The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a syst |
| 10858733006021 - MI CUFF - Aortic Root Exposure Device | 2024-05-01The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange. |
| 10858733006021 - MI CUFF - Aortic Root Exposure Device | 2024-05-01 The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root an |
| 10858733006038 - COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle | 2024-05-01 The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise sutu |
| 10858733006045 - SUTURE BELT - Circumferential Suture Organizer | 2024-05-01 The Suture Belt device is a circumferential surgical suture organizer that mounts to a retractor rack prior to use. The device i |
| 00858733006062 - Joseph Lamelas Intercostal Retractor System Rack | 2024-05-01 The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory com |
| 00858733006086 - MI Intercostal Retractor System (IRS) 222 Small Blade Set | 2024-05-01 The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory com |