| Primary Device ID | 48437006085067 |
| NIH Device Record Key | c6170e9d-e7d1-46df-92e5-fe3c3ea80919 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cranial LOOP XL |
| Version Model Number | FC050200 |
| Company DUNS | 465890437 |
| Company Name | NEOS SURGERY SL |
| 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 |
| Phone | 093 594 4726 |
| info@neosurgery.com | |
| Phone | 093 594 4726 |
| info@neosurgery.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18437006085066 [Primary] |
| GS1 | 28437006085063 [Package] Contains: 18437006085066 Package: [64 Units] In Commercial Distribution |
| GS1 | 38437006085060 [Package] Contains: 18437006085066 Package: [6 Units] In Commercial Distribution |
| GS1 | 48437006085067 [Package] Contains: 38437006085060 Package: [10 Units] In Commercial Distribution |
| GXR | Cover, Burr Hole |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-02-04 |
| 48437006085043 - Cranial LOOP | 2018-07-06 Cranial Fixation System |
| 18437006085059 - Cranial LOOP L | 2018-07-06 Cranial Fixation System |
| 48437006085067 - Cranial LOOP XL | 2018-07-06Cranial Fixation System |
| 48437006085067 - Cranial LOOP XL | 2018-07-06 Cranial Fixation System |