| Primary Device ID | 00817438026409 |
| NIH Device Record Key | c2959357-ef3d-4640-b611-9026e448d9d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | ZHS-145 |
| Company DUNS | 808825038 |
| Company Name | Omega Surgical Instruments Inc |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com | |
| Phone | 8106959800 |
| complaints@omegasurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817438026409 [Primary] |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
[00817438026409]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-13 |
| Device Publish Date | 2022-12-05 |
| 00817438022005 | 2.0 MM X 35.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438021992 | 1.5 MM X 35.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438027659 | 2.5 MM X 170.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438025969 | 2.0 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE |
| 00817438025952 | 2.0 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438025945 | 1.5 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE |
| 00817438025938 | 1.5 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438025921 | 1.1 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE |
| 00817438025914 | 1.1 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438024276 | 4.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024269 | 4.5 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024252 | 4.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024245 | 3.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024238 | 3.2 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024221 | 2.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024214 | 2.4 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024207 | 2.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024191 | 1.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE |
| 00817438024153 | 1.8 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024146 | 4.5 MM X 145.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024139 | 3.5 MM X 110.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024122 | 3.2 MM X 145.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024115 | 2.8 MM X 185.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024108 | 2.7 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024092 | 2.5 MM X 110.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024085 | 2.5 MM X 95.0 MM STAINLESS STEEL TWIST DRILL BIT, 2 FLUTE, TIN COATED |
| 00817438024078 | 2.0 MM X 85.0 MM STAINLESS STEEL TWIST DRILL BIT, 2 FLUTE |
| 00817438024061 | 2.0 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024054 | 1.5 MM X 85.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438024047 | 1.1 MM X 60.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE |
| 00817438023064 | 1.5 MM X 4.5 MM X 70.0 MM STOP DRILL WITH J-NOTCH |
| 00817438022456 | 3.0 MM X 150.0 MM MATCH HEAD NEURO STAINLESS STEEL DRILL, 2 FLUTE |
| 00817438024498 | 3.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024481 | 3.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024474 | 3.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR W/J-NOTCH,8 FLUTE |
| 00817438024467 | 3.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 8 FLUTE |
| 00817438024436 | 2.7 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024429 | 2.7 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024412 | 2.3 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024405 | 2.3 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024399 | 2.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024382 | 2.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024375 | 1.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR W/J-NOTCH, 6 FLUTE |
| 00817438024368 | 1.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE |
| 00817438024351 | 1.8 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024344 | 1.8 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024337 | 1.5 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024320 | 1.5 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |
| 00817438024313 | 1.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE |
| 00817438024306 | 1.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE |