Cranial LOOP
GUDID 48437006085043
Cranial Fixation System
NEOS SURGERY SL
Cranial bur hole cover| Primary Device ID | 48437006085043 |
| NIH Device Record Key | 7ded4938-0c7f-4805-a250-c9b981e4334d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cranial LOOP |
| Version Model Number | FC050000 |
| 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 |
Customer Support Contacts
| Phone | 999 999 9999 |
| info@neosurgery.com | |
| Phone | 999 999 9999 |
| info@neosurgery.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18437006085042 [Primary] |
| GS1 | 28437006085049 [Package] Contains: 18437006085042 Package: [64 Units] In Commercial Distribution |
| GS1 | 38437006085046 [Package] Contains: 18437006085042 Package: [6 Units] In Commercial Distribution |
| GS1 | 48437006085043 [Package] Contains: 38437006085046 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132044
FDA Product Code
| GXR | Cover, Burr Hole |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-08 |
Devices Manufactured by NEOS SURGERY SL
| 08437006085182 - Depth Gauge | 2024-09-12 DEPTH GAUGE |
| 08437006085212 - Retractor | 2024-09-12 |
| 08437006085434 - Cutter | 2024-09-12 |
| 28437006085452 - STERN FIX | 2024-09-12 STERN FIX Sternal Stabilization System, Size 2 |
| 28437006085469 - STERN FIX | 2024-09-12 STERN FIX Sternal Stabilization System- size 3 |
| 08437006085472 - STERN FIX | 2024-09-12 STERN FIX Sternal Stabilization System-Size 4 |
| 28437006085483 - STERN FIX | 2024-09-12 STERN FIX Sternal Stabilization System- Size 5 |
| 08437006085496 - Forceps | 2024-09-12 |
Trademark Results [Cranial LOOP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRANIAL LOOP 85270675 4211699 Live/Registered |
NEOS SURGERY, S.L. 2011-03-18 |
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