| Primary Device ID | 00810607000613 |
| NIH Device Record Key | b7c69450-6662-456a-8ef3-bc8a6be19334 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dura Separator, Baker, Reusable |
| Version Model Number | 800-719 |
| Catalog Number | 800-719 |
| 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 | 00810607000613 [Primary] |
| HAO | Instrument, Surgical, Non-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810607000613]
Moist Heat or Steam Sterilization
[00810607000613]
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 |
| 00810607000613 | Dura Separator, Baker, Reusable Set Consisting Of One Each #0 Cat#800-715 ID#00810607000576,#1 |
| 00810607000606 | Dura Separator, Baker, Reusable 8.0mm #3 (Similar to Penfield#3) |
| 00810607000590 | Dura Separator, Baker, Reusable 6.0mm #2 |
| 00810607000583 | Dura Separator, Baker, Reusable 4.0mm #1 |
| 00810607000576 | Dura Separator, Baker, Reusable 2.5mm #0 |