MI Intercostal Retractor System (IRS) 222 Extra Large Blade Set MI-IRS-XLB-P01

GUDID 00858733006116

The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

Biorep Technologies, Inc.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00858733006116
• NIH Device Record Key: 8fbfa397-db91-4e87-9922-09f33b58cbe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MI Intercostal Retractor System (IRS) 222 Extra Large Blade Set
• Version Model Number: 3.0
• Catalog Number: MI-IRS-XLB-P01
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858733006116 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

[00858733006116]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-01
• Device Publish Date: 2024-04-23

Devices Manufactured by Biorep Technologies, Inc.

• 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: 2024-05-01 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
• 00858733006093 - MI Intercostal Retractor System (IRS) 222 Medium Blade Set: 2024-05-01 The Joseph Lamelas Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory com