| Primary Device ID | 00810607000446 |
| NIH Device Record Key | e3fe36ba-f8b9-424d-add5-08ea64d256af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scalp Clip Applier Acragun |
| Version Model Number | 500-100 |
| Catalog Number | 500-100 |
| 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 | 00810607000446 [Primary] |
| GDO | Applier, Surgical, Clip |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810607000446]
Moist Heat or Steam Sterilization
[00810607000446]
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 | 2017-05-01 |
| 00810607002006 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002211 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002310 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002419 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002433 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002518 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforators |
| 00810607002532 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |
| 00810607002556 - ACRA-CUT | 2018-11-22 Disposable Cranial Perforator |