| Primary Device ID | E302RFSCDDR459 |
| NIH Device Record Key | 59d99aed-dbef-438d-b4d4-62942cd20c34 |
| Commercial Distribution Discontinuation | 2017-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | RFS Instrument |
| Version Model Number | RFS-CDDR45 |
| Catalog Number | RFS-CDDR45 |
| 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 |
| Phone | +358207789500 |
| sales@bioretec.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E302RFSCDDR459 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E302RFSCDDR459]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-09-20 |
| 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 |