Integra LifeSciences Biopsy Blade, Disposable Miltex Biopblade User Manual
The MILTEX BIOPBLADE
is utilized for removal of lesions, either elevated (shave biopsy) or flat (saucerization).
INDICATIONS FOR USE:
The MILTEX BIOPBLADE
is indicated for use by a licensed medical professional to obtain a biopsy of any soft tissue.
This is a disposable product and is not sterilizable.
• Use caution when handling and disposing of this product as the blade is sharp.
• Do not use this product if the individual bag is broken as sterilization cannot be guaranteed.
• The MILTEX BIOPBLADE
is a disposable product intended for single use applications.
• Do not place on or near any products containing chlorides as rusting may occur.
CONTRAINDICATIONS/LIMITATIONS: None known.
ADVERSE REACTIONS OR SIDE EFFECTS: None known.
HOW SUPPLIED: Each MILTEX BIOPBLADE
is individually sealed in a
pouch to ensure sterility. These products are sold in boxes of 50.
1. After the site is anesthetized, remove MILTEX BIOPBLADE
from its packaging.
2. Hold the MILTEX BIOPBLADE
“bowed” between the thumb and fingers. (see fig. 1)
3. NOTE the “UP” on the MILTEX BIOPBLADE
. This should face up. (see fig. 2)
4. Remove the lesion at or just below the surface epithelium.
5. Dispose of the MILTEX BIOPBLADE
as you would dispose of a used needle.
NOT RECOMMENDED/INAPPROPRIATE USES: None known.
OTHER IMPORTANT INFORMATION: None known.
Integra York PA, Inc.
589 Davies Drive
York, PA 17402
toll free phone: 866-854-8300
Rev. C 06/13
See Instructions for Use
Consult Instructions for Use
Use by: Year-Month
Single Patient Use
Batch Code / Lot Number
To be used by or on the order of a
licensed medical professional.
Product complies with
requirements of directive
93/42/EEC for medical devices
Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
Authorized Representative in
the European Community
STERILE – STERILIZED BY IRRADIATION
Sterility guaranteed unless package opened
or damaged. Do not re-sterilize.
SYMBOLS USED ON LABELING
Instructions for Use/English
Miltex, Miltex Redefining Excellence and BiopBlade are registered trademarks of Miltex, Inc., a subsidiary of Integra LifeSciences Corporation.
The Integra wave logo is a trademark of Integra LifeSciences Corporation.
Copyright© 2009 Integra LifeSciences Corporation