| Primary Device ID | 00810607000415 |
| NIH Device Record Key | fa0322e8-b41c-458b-ad76-b80a67c6fb53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cranial Blade Disposable low speed |
| Version Model Number | 800-140 |
| Catalog Number | 800-140 |
| Company DUNS | 612611459 |
| Company Name | ACRA-CUT 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 | false |
| OTC Over-The-Counter | false |
| Phone | 9782632210 |
| info@acracut.com | |
| Phone | 9782632210 |
| info@acracut.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810607000415 [Primary] |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810607000415]
Radiation Sterilization
[00810607000415]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-01 |
| 00810607000415 | Cranial Blade Disposable Low Speed 800-140 Package of 5, Spiral Flute |
| 00810607000408 | Cranial Blade Disposable Low Speed 800-140 Single, Spiral Flute |
| 00810607000392 | Cranial Blade Disposable Low Speed 800-130 Package of 5, Straight Flute |
| 00810607000385 | Cranial Blade Disposable Low Speed 800-130 Single, Straight Flute |