| Primary Device ID | 04522281000426 |
| NIH Device Record Key | 31e79d65-34d5-42af-a383-90f0348793d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELAN 4 |
| Version Model Number | MC037 |
| Catalog Number | MC037 |
| Company DUNS | 082594540 |
| Company Name | AESCULAP, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04522281000426 [Primary] |
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-05 |
| Device Publish Date | 2020-09-25 |
| 04522281000488 | HILAN DIAMOND BURR COARSE III 5.0MM |
| 04522281000464 | HILAN DIAMOND BURR COARSE III 4.0MM |
| 04522281000457 | HILAN DIAMOND BURR COARSE II 4.0MM |
| 04522281000433 | HILAN DIAMOND BURR II 4.0MM |
| 04522281000426 | HILAN ROSEN BURR III 5.0MM |
| 04522281000419 | HILAN ROSEN BURR II 5.0MM |
| 04522281000396 | HILAN ROSEN BURR II 4.0MM |
| 04046964998539 | HILAN CRANIOTOME STRAIGHT III |
| 04046964233289 | AESCULAP ROUND BURR 3.0X70MM |
| 04046964909832 | HILAN BARREL BURR II, SMOOTH CUT 5.0MM |
| 04046964909818 | HILAN CRANIOTOME STRAIGHT II |
| 04046964246067 | AESCULAP DIAMOND BURR 5.0X70MM |
| 04046964246043 | AESCULAP DIAMOND BURR 4.0X70MM |
| 04046964246036 | AESCULAP DIAMOND BURR 3.5X70MM |
| 04046964246012 | AESCULAP DIAMOND BURR 2.5X70MM |
| 04046964246005 | AESCULAP DIAMOND BURR 2.0X70MM |
| 04046964245978 | TAPRD FLUTED PEAR BURR7X70MMDISP |
| 04046964245923 | AESCULAP ROUND BURR 6.0X70MM |
| 04046964233272 | AESCULAP ROUND BURR 2.4X70MM |
| 04046964246029 | AESCULAP DIAMOND BURR 3.0X70MM |
| 04046964233265 | AESCULAP ROUND BURR 1.8X70MM |
| 04046964245909 | AESCULAP ROUND BURR 5.0X70MM |
| 04046964245695 | AESCULAP ROUND BURR 4.5X70MM |
| 04046964245688 | AESCULAP ROUND BURR 4.0X70MM |
| 04046964245985 | AESCULAP DIAMOND BURR 1.0X70MM |
| 04046964246227 | AESCULAP ROUND BURR 1.8X95MM |
| 04046964910197 | CRANIOBLADE F/GB265 GB268 STER |
| 04046964910111 | AESCULAP BARREL BURR 5X95MM |
| 04046964910098 | FISSURE BURR CARBIDE 1.6 X 70MM |
| 04046964910074 | FISSURE BURR CARBIDE 1.2 X 70MM |
| 04046964910050 | TAPERED SIDE CUTTING BURR1.8X70MM |
| 04046964909979 | WIRE PASS DRILL 1.5X70MM |
| 04046964909955 | WIRE PASS DRILL 1.0X70MM |
| 04046964246883 | AESCULAP ROUND BURR 5.0X125MM |
| 04046964246784 | FAST CUT BARREL BURR 5X95MM DISP |
| 04046964246289 | AESCULAP ROUND BURR 5.0X95MM |
| 04046964246265 | AESCULAP ROUND BURR 4.0X95MM |
| 04046964246258 | AESCULAP ROUND BURR 3.5X95MM |
| 04046964246210 | AESCULAP EGG BURR 4X70MM |
| 04046964246197 | AESCULAP PEAR BURR 6X70MM |
| 04046964246180 | AESCULAP BARREL BURR 6X70MM |
| 04046964246173 | AESCULAP BARREL BURR 5X70MM |
| 04046964246166 | AESCULAP BARREL BURR 4X70MM |
| 04046964246074 | AESCULAP DIAMOND BURR 6.0X70MM |
| 04046964246104 | LINDEMANN BURR 1.5X24X70MM |
| 04046964246098 | LINDEMANN BURR 1.5X14X70MM |
| 04046964603136 | HI-LINE XS NEURO SMOOTH CUT III D3.0MM |
| 04046964603129 | HI-LINE XS NEURO SMOOTH CUT II D3.0MM |
| 04046964603105 | HI-LINE XS NEURO SMOOTH CUT III D2.5MM |
| 04046964603099 | HI-LINE XS NEURO SMOOTH CUT II D2.5MM |