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 table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037506132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037506132008500375061328500375061320850037506132

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA 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 table
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 table
Primary DIBrandModelCatalogPublished
00850037506101Cutting Block890542022-11-09
00850037506057MACI Arthroscopic Instruments82024N/A2024-09-18
00850037506224MACI Arthroscopic Instruments82034N/A2024-09-18
00850037506262MACI Arthroscopic Instruments82038N/A2024-09-18
00850037506002MACI Arthroscopic Instruments82032N/A2024-08-26
00850037506019MACI Arthroscopic Instruments82023N/A2024-08-26
00850037506026MACI Arthroscopic Instruments82021N/A2024-08-26
00850037506033MACI Arthroscopic Instruments82020N/A2024-08-26
00850037506040MACI Arthroscopic Instruments82022N/A2024-08-26
00850037506064MACI Arthroscopic Instruments82026N/A2024-08-26
00850037506088MACI Arthroscopic Instruments82016N/A2024-08-26
00850037506217MACI Arthroscopic Instruments82033N/A2024-08-26
00850037506231MACI Arthroscopic Instruments82035N/A2024-08-26
00850037506248MACI Arthroscopic Instruments82036N/A2024-08-26
00850037506255MACI Arthroscopic Instruments82037N/A2024-08-26
00850037506279MACI Arthroscopic Instruments89060N/A2024-08-26
00860004093022MACI Arthroscopic Instruments82017N/A2024-08-26
00860004093039MACI Arthroscopic Instruments82018N/A2024-08-26
00860004093046MACI Arthroscopic Instruments82025N/A2024-08-26
00860004093053MACI Arthroscopic Instruments82027N/A2024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
18257200028177PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028207PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028917FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028924FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028931FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028948FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028955FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028979FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028986FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028993FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029006FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029013FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029020FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029280FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029846FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029853FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029860FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029877FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029884FIREBIRD SFSOrthofix US LLCFSM2026-07-17