| Primary Device ID | 00810607000521 |
| NIH Device Record Key | e566e2e2-7fb4-4b7e-8a4a-80b3a2d4dde5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dura Separator, Standard, Reusable |
| Version Model Number | 800-710 |
| Catalog Number | 800-710 |
| Company DUNS | 612611459 |
| Company Name | ACRA-CUT 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00810607000521 [Primary] |
| HAO | Instrument, Surgical, Non-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810607000521]
Moist Heat or Steam Sterilization
[00810607000521]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-01 |
| 00810607000569 | Dura Separator, Standard, Reusable Set Consisting Of One Each #0 Cat#800-710 ID#00810607000521 |
| 00810607000552 | Dura Separator, Standard, Reusable 8.0mm #3 (Similar to Penfield#3) |
| 00810607000545 | Dura Separator, Standard, Reusable 6.0mm #2 |
| 00810607000538 | Dura Separator, Standard, Reusable 4.0mm #1 |
| 00810607000521 | Dura Separator, Standard, Reusable 2.5mm #0 |