| Primary Device ID | 04026575434985 |
| NIH Device Record Key | ac29cdf2-47ec-4ed0-950f-07bd89ac79bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instruments for Revision Surgery |
| Version Model Number | 175-700 |
| Company DUNS | 315675488 |
| Company Name | WALDEMAR LINK GmbH & Co. KG |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04026575434985 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
[04026575434985]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-26 |
| 04026575331185 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø16.0 mm, AO Fitting [D] |
| 04026575331147 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø14.0 mm, Jacobs Fitting [E] |
| 04026575331130 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø14.0 mm, AO Fitting [D] |
| 04026575331093 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø12.0 mm, Jacobs Fitting [E] |
| 04026575331086 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø12.0 mm, AO Fitting [D] |
| 04026575331048 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø10.0 mm, Jacobs Fitting [E] |
| 04026575331031 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø10.0 mm, AO Fitting [D] |
| 04026575330997 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø8.0 mm, Jacobs Fitting [E] |
| 04026575330980 | Ball Reamer, Stainless Steel, Total L=400 mm, Ø8.0 mm, AO Fitting [D] |
| 04026575330935 | Twist Drill, Stainless Steel, Total L=400 mm, Ø10.0 mm, AO Fitting [D] |
| 04026575330928 | Twist Drill, Stainless Steel, Total L=400 mm, Ø10.0 mm, Harris Fitting [C] |
| 04026575330881 | Twist Drill, Stainless Steel, Total L=400 mm, Ø8.0 mm, AO Fitting [D] |
| 04026575330874 | Twist Drill, Stainless Steel, Total L=400 mm, Ø8.0 mm, Harris Fitting [C] |
| 04026575330836 | Twist Drill, Stainless Steel, Total L=400 mm, Ø6.0 mm, AO Fitting [D] |
| 04026575194599 | Instrument Tray, empty, Stainless Steel |
| 04026575194582 | Instrument Tray, empty, Stainless Steel |
| 04026575194575 | Instrument Tray, empty, Stainless SteelI |
| 04026575033577 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled inner edge, L=310 mm, W=10 mm |
| 04026575033560 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled inner edge, L=310 mm, W=7 mm |
| 04026575033553 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled inner edge, L=310 mm, W=5 mm |
| 04026575033546 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled outer edge, L=310 mm, W=10 mm |
| 04026575033539 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled outer edge, L=310 mm, W=7 mm |
| 04026575033522 | Bone Cement Gouge, Stainless Steel, Version= straight, bevelled outer edge, L=310 mm, W=5 mm |
| 04026575434985 | Instrument Tray, empty, Stainless Steel |