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Blayco biopsy punches

Blayco biopsy punches
3Pages

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Technical data sheet Product description The device is used for obtaining full-thickness skin specimen for the biopsy test. 2460 Product charasteristics • Sterile product by Gamma irradiation. • Shelf life: 5 years upon the manufacturing date. B Materials • Tip: Stainless Steel. • Handle: ABS. . CAP: LDPE. • Primary packaging: Medical grade. B Main dimensional properties • BPS10: 1 mm diameter. • BPS20 : 2 mm diameter. • BPS30: 3 mm diameter. • BPS40: 4 mm diameter. • BPS50: 5 mm diameter. • BPS60: 6 mm diameter. • BPS70: 7 mm diameter. • BPS80: 8 mm diameter. This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 1 - 3

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Technical data sheet B Biocompatibility • ISO 10993-5: No cytotoxic. • ISO 10993-4: Hemocompatible. • ISO 10993-10: No sensitizing. • ISO 10993-10: Negative intracutaneous irritation test. Conclusion: product is biocompatible. B Storage and maintenance • Keep protected from direct sunlight / the outside. • Keep in a dry place. • Temperature range: 10°C - 40°C. • Single use product. No maintenance required. B Packaging # Ref Packaging BPS10 BPS1.0 Individual pouch, in case of 10 units. BPS20 BPS2.0 Individual pouch, in case of 10 units. BPS30 BPS3.0 Individual pouch, in case of 10 units....

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TECHNICAL DATA SHEET Regulatory informa on TELIC, S.A.U. guarantees that this product is in conformity with Direc ve 93/42/EEC and that it has been manufactured following the direc ves of the Quality Assurance System cer ﬁed as ISO 13485. This product is classiﬁed as: Class IIa product according to Annex IX of Direc ve 93/42/EEC, rule 6. GMDN code: 35286. This document is the property of Telic, S.A.U. Transmission to third-par es or non-authorized copies are not allowed 3-3

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Blayco biopsy punches 3Pages

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Blayco biopsy punches
3Pages