| Primary Device ID | 05056139202285 |
| NIH Device Record Key | 67c04bea-7348-4148-bcf6-b5f87dd6df3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HLS Noetos Revision |
| Version Model Number | GDF544 |
| Catalog Number | GDF544 |
| Company DUNS | 295437313 |
| Company Name | CORIN LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +330456608978 |
| severine.siracusa@coringroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056139202285 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05056139202285]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-08-28 |
| 05056139233302 | HLS Noets Revision Extended stem L150mm D22mm |
| 05056139233296 | HLS Noets Revision Extended stem L150mm D20mm |
| 05056139233289 | HLS Noets Revision Extended stem L75mm D22mm |
| 05056139233272 | HLS Noets Revision Extended stem L75mm D20mm |
| 05056139218347 | Trial stem extension Ø18mm L.50mm |
| 05056139218330 | Trial stem extension Ø16mm L.50mm |
| 05056139218323 | Trial stem extension Ø14mm L.50mm |
| 05056139218316 | Trial stem extension Ø12mm L.50mm |
| 05056139218309 | Trial stem extension Ø10mm L.50mm |
| 05056139217319 | Cutting guide support stem |
| 05056139217241 | Stem femoral adaptor key N°6 |
| 05056139217234 | Stem femoral adaptor key N°5 |
| 05056139217227 | Stem femoral adaptor key N°4 |
| 05056139217210 | Stem femoral adaptor key N°3 |
| 05056139217203 | Stem femoral adaptor key N°2 |
| 05056139217197 | Stem femoral adaptor key N°1 |
| 05056139217180 | Stem assembly key Ø10-18mm |
| 05056139217166 | Finless tibial punch sizes 3-4-5-6 |
| 05056139217159 | Finless tibial punch sizes 1-2 |
| 05056139217142 | 3.5 mm headed pin |
| 05056139217135 | Tibial component adaptor S3-4-5-6 |
| 05056139217128 | Tibial component adaptor S1-2 |
| 05056139217111 | Augment feeler height 12mm |
| 05056139217104 | 4.5mm univ. screwdriver across flat |
| 05056139217098 | 2.5mm universal screwdriver across flat |
| 05056139217081 | Augment feeler height 8mm |
| 05056139217074 | Augment feeler height 4mm |
| 05056139217067 | Trial flange 9° Left |
| 05056139217050 | Trial flange 7° Left |
| 05056139217043 | Trial flange 5° Left |
| 05056139217036 | Trial flange 9° Right |
| 05056139217029 | Trial flange 7° Right |
| 05056139217012 | Trial flange 5° Right |
| 05056139217005 | Trial sledge 9° |
| 05056139216992 | Trial sledge 7° |
| 05056139216985 | Trial sledge 5° |
| 05056139216978 | Trial femoral stem bridge size 6 |
| 05056139216961 | Trial femoral stem bridge size 5 |
| 05056139216954 | Trial femoral stem bridge size 4 |
| 05056139216947 | Trial femoral stem bridge size 3 |
| 05056139216930 | Trial femoral stem bridge size 2 |
| 05056139216923 | Trial femoral stem bridge size 1 |
| 05056139216916 | Trial Femoral Posterior Augment S5-6 H8mm |
| 05056139216909 | Trial Femoral Posterior Augment S2-3-4 H8mm |
| 05056139216893 | Trial Femoral Posterior Augment S1 H8mm |
| 05056139216886 | Trial Femoral Posterior Augment S5-6 H4mm |
| 05056139216879 | Trial Femoral Posterior Augment S2-3-4 H4mm |
| 05056139216862 | Trial Femoral Posterior Augment S1 H4mm |
| 05056139216855 | Trial Femoral Distal Augment S5-6 H12mm |
| 05056139216848 | Trial Femoral Distal Augment S2-3-4 H12mm |