Integra LifeSciences Biopsy Blade, Disposable Miltex Biopblade - Manual

PRODUCT USE:
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.
WARNINGS/PRECAUTIONS:
• 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.
STEP-BY-STEP INSTRUCTIONS:
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.
Manufactured for:
Integra York PA, Inc.
589 Davies Drive
York, PA 17402
toll free phone: 866-854-8300
phone: 717-840-9335
fax: 717-840-9347
www.miltex.com
Rev. C 06/13 SURG-BIOPBL-DFU
fig. 2
See Instructions for Use
Consult Instructions for Use
Use by: Year-Month
Single Patient Use
Batch Code / Lot Number
Catalog Number
To be used by or on the order of a
licensed medical professional.
LOT
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
EC REP
Authorized Representative in
the European Community
EC REP
STERILE – STERILIZED BY IRRADIATION
Sterility guaranteed unless package opened
or damaged. Do not re-sterilize.
SYMBOLS USED ON LABELING
MILTEX BIOPBLADE ®
Instructions for Use/English
ONLY
0297
fig. 1
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