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Non-Sterile Single Use Scalpel Handle, No.3 125 mm


Article: Number BTBB0733
General Description: Scalpel Handle, No. 3
Size:  125mm


UDI – DI: *+G075BTBB07330F*
EMDN Code: K01020201
Classification – Rule: Class IIA (non-sterile) according to Rule 6 Annex IX MDD 93/42/EEC

Justification: Single use- Surgical Invasive, Transient use

Technical Specification

Application / Intended Use:
Raw materials: Stainless steel AISI 410
Surface: Matt Finish/Mirror
Standard Reference: ASTM F899-11 & ISO 7153-1
Environment: Harmless
Bio-burden per Non-Sterile Device CFU/Device ≤100 CFU
Bio-burden per Sterile Device CFU/Device
Biocompatible material according to subject standards: EN ISO 10993-10:2010 (Intradermal Reactivity Test), EN ISO 10993-11:2017 (Acute Systemic Toxicity Test), EN ISO 10993-11:2017 (Material Mediated Pyrogens Test), EN ISO 10993-10:2010 (Skin Sensitization Test), EN ISO 10993-5:2009 (In Vitro Cytotoxicity Test)
ETO Sterilisable as per subject limits: Concentration ETO: 600 ± 50mg/l

Temperature: 54°C – 55°C

Exposure time: 6 Hours

Humidity: 60-70% RH minimum

Shelf life: Shelf life is 5 years for Sterile and 2 years for non-sterile items
Etching/Marking: Beauty Teck can provide the Etching/Marking as per client requirement within the MDD/MDR regulation.
Colour marking/Identification of single use instrument: Colour marking or identification of single use instrument should be coloured as per client demand. If client required blue, red or any other colour BTI should provide the colour accordingly.

All colour scheme is compatible with ETO sterilization.

Biocompatibility testing done for Colour instruments after ETO Sterilization.

Coloured instruments are 100% biocompatible and comply ETO sterilization requirements.

Instruction For Use