Huvex SO.IM.0010L
GUDID 08800039820554
Huvex 10mm
DIOMEDICAL CO.,LTD.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 08800039820554 |
| NIH Device Record Key | e3a5c892-031e-47ca-bd5d-4ea6c429220c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Huvex |
| Version Model Number | A |
| Catalog Number | SO.IM.0010L |
| Company DUNS | 557795909 |
| Company Name | DIOMEDICAL CO.,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800039820554 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162849
FDA Product Code
| PEK | Spinous process plate |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
[08800039820554]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-22 |
| Device Publish Date | 2020-07-14 |
On-Brand Devices [Huvex]
| 08800039820585 | BONE PACKING BLOCK |
| 08800039820578 | Huvex 14mm |
| 08800039820561 | Huvex 12mm |
| 08800039820554 | Huvex 10mm |
| 08800039820547 | Huvex 8mm |
| 08800039820530 | Huvex 6mm |
| 08800113935563 | Huvex Interspinous Fixation System (A)15.8x(B)45x(C)3x(D)9.8mm-Bar 27mm |
Trademark Results [Huvex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HUVEX 79184635 5168927 Live/Registered |
DIOMEDICAL Co., Ltd. 2016-01-18 |
 HUVEX 78790362 not registered Dead/Abandoned |
WACKER NEUSON CORPORATION 2006-01-12 |
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