MARROWMAX BONE MARROW ASPIRATION
NEEDLE KIT
NeedleTech Products, Inc.
452 John L. Dietsch Blvd.
No. Attleboro, MA 02763 USA
Telephone: 508 431 4000
Fax 508 222 2852
ENGLISH
IMPORTANT INFORMATION ON THE
MARROWMAX BONE MARROW ASPIRATION NEEDLE KIT
PURPOSE
Designed specifically for bone marrow aspiration and/or autologous blood, the MARROWMAX Bone
Marrow Aspiration Needle Kit provides a safe and simple technique for aspirating marrow and/or
autologous blood.
The product label for the MARROMAX Bone Marrow Aspiration Needle Kit configuration uses symbols to
convey essential product information. Each symbol is defined in Table 1.
SYMBOL MEANING
Rx Only
Table 1: Definition of Symbols
Caution, Federal (US) Law restricts this device to sale by or on the order of a licensed
physician
Do not reuse
Use by
NEEDLETECH PRODUCTS, INC. Page 1 of 3
Batch code
Manufacturing date
Catalog number
Sterilized using ethylene oxide
Do not use if package is damaged
Consult instruction for use
Manufactured by
DESCRIPTION
The MARROWMAX Bone Marrow Aspiration Needle Kit consists of 1 FDA cleared and 1 legally marketed
device; the Becton Dickinson Single Use Hypodermic Syringes (K980987) and the NeedleTech Products,
Inc. Bone Marrow Biopsy Needle (510K Exempt).
The NeedleTech Products, Inc. Bone Marrow Biopsy Needle consists of a needle and a trocar tip stylet of
corresponding size. The needle will be manufactured with a length of 6 inches. The needle contains a
female Luer-lok™ connection to allow aspiration of bone marrow and/or blood by use of a standard Luerlok™ surgical syringe. The needle will be provided with three fenestrated holes located on the distal end
of the cannula. There will be another needle available with one fenestrated hole on the distal end of the
cannula.
NeedleTech Products, Inc. Bone Marrow Biopsy Needle will be packaged in a kit that will include a 10mL
or 20mL BD Luer-Lok™ syringe.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
INDICATIONS
The MARROWMAX Bone Marrow Aspiration Needle Kit is a stylet/cannula system to be used to obtain
bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.
CONTRAINDICATIONS
The MARROWMAX Bone Marrow Aspiration Needle Kit should not be used in the presence of active or
suspected infection.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to wound complications including hematoma, site
damage, infection, bone fracture, and other complications common to any surgical procedure.
WARNING(S) and PRECAUTIONS
Use aseptic technique in all phases of handling.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the
patient, the important medical information given in this document should be conveyed to the patient.
USA
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.
NEEDLETECH PRODUCTS, INC. Page 2 of 3
FOR US AUDIENCES ONLY