MACI Surgical Implantation Kit
- Primary DI
- 00850037506132
- Brand
- MACI Surgical Implantation Kit
- Company
- VERICEL CORPORATION
- Model
- N/A
- Device description
- The MACI Surgical Implantation Kit is intended to assist with MACI® (autologous cultured chondrocytes on porcine collagen membrane) knee surgery. The kit contains instruments to assist surgeons with preparing the defect, cutting the implant, and transferring the implant.The MACI Surgical Implantation Kit contains:1 - Sterilization Tray;1 - Silicone Cutting Block, Single Use Only;1 - Tungsten Carbide Scissors, manufactured by Symmetry Surgical, Inc.;2 - Toothless Adsons, manufactured by Symmetry Surgical, Inc.;1 - 4.5mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - 6.0mm Ring Curette, manufactured by Richard Wolf Medical Instruments Corp.; 1 - Mallet, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 13X20mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 15X23mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 20X25mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oval 22X32mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D15mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Round D28mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC;1 - Cutter Oblong 10X30mm, manufactured by Aesculap, Inc. or Disruptive Medtech, LLC
- Published
- 2022-11-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850037506132 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850037506132 | 00850037506132 | 850037506132 | 0850037506132 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 079745570
- Device count
- 1
- Kit
- true
- Serial number
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850037506101 | Cutting Block | 89054 | 2022-11-09 | |
| 00850037506057 | MACI Arthroscopic Instruments | 82024 | N/A | 2024-09-18 |
| 00850037506224 | MACI Arthroscopic Instruments | 82034 | N/A | 2024-09-18 |
| 00850037506262 | MACI Arthroscopic Instruments | 82038 | N/A | 2024-09-18 |
| 00850037506002 | MACI Arthroscopic Instruments | 82032 | N/A | 2024-08-26 |
| 00850037506019 | MACI Arthroscopic Instruments | 82023 | N/A | 2024-08-26 |
| 00850037506026 | MACI Arthroscopic Instruments | 82021 | N/A | 2024-08-26 |
| 00850037506033 | MACI Arthroscopic Instruments | 82020 | N/A | 2024-08-26 |
| 00850037506040 | MACI Arthroscopic Instruments | 82022 | N/A | 2024-08-26 |
| 00850037506064 | MACI Arthroscopic Instruments | 82026 | N/A | 2024-08-26 |
| 00850037506088 | MACI Arthroscopic Instruments | 82016 | N/A | 2024-08-26 |
| 00850037506217 | MACI Arthroscopic Instruments | 82033 | N/A | 2024-08-26 |
| 00850037506231 | MACI Arthroscopic Instruments | 82035 | N/A | 2024-08-26 |
| 00850037506248 | MACI Arthroscopic Instruments | 82036 | N/A | 2024-08-26 |
| 00850037506255 | MACI Arthroscopic Instruments | 82037 | N/A | 2024-08-26 |
| 00850037506279 | MACI Arthroscopic Instruments | 89060 | N/A | 2024-08-26 |
| 00860004093022 | MACI Arthroscopic Instruments | 82017 | N/A | 2024-08-26 |
| 00860004093039 | MACI Arthroscopic Instruments | 82018 | N/A | 2024-08-26 |
| 00860004093046 | MACI Arthroscopic Instruments | 82025 | N/A | 2024-08-26 |
| 00860004093053 | MACI Arthroscopic Instruments | 82027 | N/A | 2024-08-26 |
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