Cutting Block

GUDID 00850037506101

The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) implant during implantation surgery. The Cutting Block may be supplied individually in a sealed pouch, or it may be supplied unwrapped as part of the MACI Surgical Implantation Kit.

VERICEL CORPORATION

Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use Surgical cutting/shaping board, single-use
Primary Device ID00850037506101
NIH Device Record Key16174c91-efe7-4d0a-ad68-fc569077aab0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCutting Block
Version Model Number89054
Company DUNS079745570
Company NameVERICEL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037506101 [Primary]

FDA Product Code

KDCInstrument, Surgical, Disposable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


[00850037506101]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-17
Device Publish Date2022-11-09

Devices Manufactured by VERICEL CORPORATION

00850037506194 - Cartilage Biopsy Transport Kit2023-08-10 The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage b
00850037506101 - Cutting Block2022-11-17The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) implant during implantation surgery. The Cutting Block may be supplied individually in a sealed pouch, or it may be supplied unwrapped as part of the MACI Surgical Implantation Kit.
00850037506101 - Cutting Block2022-11-17 The Cutting Block is intended to provide a sterile cutting surface during surgery. The Cutting Block may be used for cutting MAC
00850037506132 - MACI Surgical Implantation Kit2022-11-17 The MACI Surgical Implantation Kit is intended to assist with MACI® (autologous cultured chondrocytes on porcine collagen membr
00850037506170 - Blood Collection Kit2022-10-03 The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. Th
00850037506095 - Sterilization Tray2022-07-25
00860004093008 - Skin Biopsy Transport Kit2020-10-02 The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and
00860004093015 - Cartilage Biopsy Transport Kit2020-10-02 The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage b

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