RFS Instrument RFS-CS35

GUDID E302RFSCS359

RFS™ Countersink 2.7/3.5mm

Bioretec Oy

Surgical countersink, reusable

• Primary Device ID: E302RFSCS359
• NIH Device Record Key: d32ab8fe-3ba5-43ce-80d3-2efb0f26c356
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RFS Instrument
• Version Model Number: RFS-CS35
• Catalog Number: RFS-CS35
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +358207789500
• Email: sales@bioretec.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302RFSCS359 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E302RFSCS359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-23

On-Brand Devices [RFS Instrument]

• E302RFSDS459: RFS™ Drill Sleeve 4.5mm
• E302RFSDS359: RFS™ Drill Sleeve 3.5mm
• E302RFSDS279: RFS™ Drill Sleeve 2.7mm
• E302RFSCPS9: RFS Cannulated Protection Sheath
• E302RFSCDS459: RFS Cannulated Drill Sleeve 3.5/4.5
• E302RFSCDS359: RFS Cannulated Drill Sleeve 2.7/3.5
• E302RFSTA45S9: RFS™ Tap 4.5mm x 125mm
• E302RFSTA459: RFS™ Tap 4.5mm x 180mm
• E302RFSTA359: RFS™ Tap 3.5mm
• E302RFSTA279: RFS™ Tap 2.7mm
• E302RFSSGW279: K-wires (10 pcs) for 2.7mm RFS™ Pin
• E302RFSSGW159: K-wire Ø1.6 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs.
• E302RFSPDR279: RFS™ Pin Drill 2.7mm
• E302RFSPDR209: RFS™ Pin Drill 2.0mm
• E302RFSPDR159: RFS™ Pin Drill 1.5mm
• E302RFSPAR279: RFS™ Reusable Pin Applicator 2.7mm
• E302RFSPAR209: RFS™ Reusable Pin Applicator 2.0mm
• E302RFSPAR159: RFS™ Reusable Pin Applicator 1.5mm
• E302RFSHS459: RFS™ Holding Sleeve 4.5mm
• E302RFSHS359: RFS™ Holding Sleeve 2.0/2.7/3.5mm
• E302RFSDR32S9: RFS™ Drill 3.2mm x 145mm
• E302RFSDR329: RFS™ Drill 3.2mm x 185mm
• E302RFSDR259: RFS™ Drill 2.5mm
• E302RFSDR209: RFS™ Drill 2.0mm
• E302RFSDI359: RFS™ Driver Insert 3.5mm
• E302RFSDI259: RFS™ Driver Insert 2.5mm
• E302RFSDGL9: RFS™ Depth Gauge Large
• E302RFSCTHDL9: RFS Cannulated T-Handle
• E302RFSCTA459: RFS™ Cannulated TAP 4.5
• E302RFSCTA409: RFS™ Cannulated TAP 4.0
• E302RFSCTA359: RFS™ Cannulated TAP 3.5
• E302RFSCSR019: RFS Cannulated Instrument Set
• E302RFSCS9: RFS cannulated instrument tray
• E302RFSCS459: RFS™ Countersink 4.5mm
• E302RFSCS359: RFS™ Countersink 2.7/3.5mm
• E302RFSCKW160T9: RFS™ K-Wire 1.60 x 15 trocar
• E302RFSCKW1609: RFS™ K-Wire 1.60 x 15 Threaded
• E302RFSCKW125T9: RFS™ K-Wire 1.25 x 15 trocar
• E302RFSCKW1259: RFS™ K-Wire 1.25 x 15 Threaded
• E302RFSCHS459: RFS™ Cannulated Holding Sleeve 4.0/4.5
• E302RFSCHS359: RFS Cannulated Hex Shaft 3.5
• E302RFSCHS259: RFS Cannulated Hex Shaft 2.5
• E302RFSCHDL9: RFS Cannulated Handle Large
• E302RFSCDR359: RFS™ Cannulated Drill 3.5
• E302RFSCDR329: RFS™ Cannulated Drill 3.2
• E302RFSCDR279: RFS™ Cannulated Drill 2.7
• E302RFSCDG9: RFS Cannulated Depth Gauge
• E302RFSCDDR459: RFS Cannulated Direct driver 4.5
• E302RFSCDDR359: RFS Cannulated Direct driver 3.5
• E302RFSCCS9: RFS™ Cannulated Countersink