| Primary Device ID | 04048266076823 |
| NIH Device Record Key | eb505005-0d06-4296-8fb2-00fe60f9c31b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | FH20050 |
| Company DUNS | 313267265 |
| Company Name | Merete GmbH |
| 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 | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266076823 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
[04048266076823]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-09 |
| Device Publish Date | 2024-07-01 |
| 04048266177346 | Screwdriver #10 Star 70 AO-Connector color-coated blue green and yellow non-sterile |
| 04048266177339 | Screwdriver #8 Star 70 AO-Connector color-coated white and magenta non-sterile |
| 04048266177308 | Screw Extractor for cannulated Screws AO-Connector non-sterile |
| 04048266177292 | Counter Sink 2.0-4.0 with Length Gauge 0-50 for 1.4 K-Wire non-sterile |
| 04048266177285 | Tissue Protector for Drill 7.0 and Over-Drill 7.0 color-coated purple non-sterile |
| 04048266177278 | Tissue Protector for Drill 4.0 and Over-Drill 4.0 color-coated yellow non-sterile |
| 04048266177261 | Tissue Protector for Drill 3.5 and Over-Drill 3.5 color-coated green non-sterile |
| 04048266177254 | Tissue Protector for Drill 3.0 and Over-Drill 3.0 color-coated blue non-sterile |
| 04048266177247 | Tissue Protector for Drill 2.5 and Over-Drill 2.5 color-coated magenta non-sterile |
| 04048266177230 | Tissue Protector for Drill 2.0 and Over-Drill 2.0 color-coated white non-sterile |
| 04048266177223 | Counter Sink headless Screws 7.0 70 AO-Connector color-coated purple non-sterile |
| 04048266177216 | Counter Sink headless Screws 4.0 70 AO-Connector color-coated yellow non-sterile |
| 04048266177209 | Counter Sink headless Screws 3.5 70 AO-Connector color-coated green non-sterile |
| 04048266177193 | Counter Sink headless Screws 3.0 70 AO-Connector color-coated blue non-sterile |
| 04048266177186 | Counter Sink headless Screws 2.5 70 AO-Connector color-coated magenta non-sterile |
| 04048266177179 | Counter Sink headless Screws 2.0 70 AO-Connector color-coated white non-sterile |
| 04048266177162 | Counter Sink Headed-Screws 7.0 70 AO-Connector color-coated purple non-sterile |
| 04048266177155 | Counter Sink Headed-Screws 4.0 70 AO-Connector color-coated yellow non-sterile |
| 04048266177148 | Counter Sink Headed-Screws 3.5 70 AO-Connector color-coated green non-sterile |
| 04048266177131 | Counter Sink Headed-Screws 3.0 70 AO-Connector color-coated blue non-sterile |
| 04048266177124 | Counter Sink Headed-Screws 2.5 70 AO-Connector color-coated magenta non-sterile |
| 04048266177117 | Counter Sink Headed-Screws 2.0 70 AO-Connector color-coated white non-sterile |
| 04048266177100 | Tap 7.0 210 AO-Connector color-coated purple non-sterile |
| 04048266177094 | Over-Drill 7.0 210 AO-Connector color-coated purple non-sterile |
| 04048266177087 | Over-Drill 4.0 140 AO-Connector color-coated yellow non-sterile |
| 04048266177070 | Over-Drill 3.5 140 AO-Connector color-coated green non-sterile |
| 04048266177063 | Over-Drill 3.0 140 AO-Connector color-coated blue non-sterile |
| 04048266177056 | Over-Drill 2.5 140 AO-Connector color-coated magenta non-sterile |
| 04048266177049 | Over-Drill 2.0 140 AO-Connector color-coated white non-sterile |
| 04048266177032 | Drill 7.0 210 AO-Connector color-coated purple non-sterile |
| 04048266177025 | Drill 4.0 140 AO-Connector color-coated yellow non-sterile |
| 04048266177018 | Drill 3.5 140 AO-Connector color-coated green non-sterile |
| 04048266177001 | Drill 3.0 140 AO-Connector color-coated blue non-sterile |
| 04048266176998 | Drill 2.5 140 AO-Connector color-coated magenta non-sterile |
| 04048266176981 | Drill 2.0 140 AO-Connector color-coated white non-sterile |
| 04048266167378 | Screwdriver with Handle T10 non-sterile |
| 04048266167361 | Screwdriver with Handle T8 non-sterile |
| 04048266167309 | Universal Length Gauge for K-Wire 150 mm non-sterile |
| 04048266166838 | T-Handle with AO-Connector non-sterile |
| 04048266166142 | Screw Driver T10 70 AO-Connector non-sterile |
| 04048266165855 | Step K-Wire with threaded trocar tip round tip 1.4 40 Stainless Steel non-sterile Unit/ 4 pcs. |
| 04048266165848 | Olive K-Wire with threaded trocar tip round tip 1.4 40 Stainless Steel non-sterile Unit/ 4 pcs. |
| 04048266165831 | Olive K-Wire with trocar tip round end 1.4 40 Stainless Steel non-sterile Unit/ 4 pcs. |
| 04048266165510 | Countersink 7.0 with length gauge 0-50 for 1.4 K-Wire non-sterile |
| 04048266162168 | Drill Bit 3.2 120 AO-Connector small non-sterile |
| 04048266155658 | K-Wire threaded tip round end DIA 2.0 mm Length 230 mm Implant Steel non-sterile 1 pcs. |
| 04048266151209 | 3D-Saw Template for Scarf/ Chevron Osteotomie non-sterile |
| 04048266144720 | Spherical Reamer 61 non-sterile |
| 04048266144713 | Screwdriver T10 70 cannulated for DIA 1.4 K-Wire AO-Connector small non-sterile |
| 04048266144706 | Screwdriver Hex 2.5 70 cannulated for DIA 1.4 K-Wire AO-Connector small non-sterile |