| Primary Device ID | 08800039887311 |
| NIH Device Record Key | 0e55ce0f-867c-4abb-86f7-7ce063ffdce2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balteum |
| Version Model Number | A |
| Catalog Number | AL.IN.0004 |
| 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 |
| 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 | |
| Phone | +82313699470 |
| info@huvexel.com | |
| Phone | +82313699470 |
| info@huvexel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800039887311 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
[08800039887311]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-13 |
| Device Publish Date | 2022-12-05 |
| 08800113999114 | Temporary Fixation pin |
| 08800039887335 | Awl for Drill Guide |
| 08800039887328 | Awl with Sleeve |
| 08800039887311 | Variable drill guide (single barrel) |
| 08800039887304 | Self-retaining Screwdriver T20 |
| 08800039874984 | Lumbar Plate Variable screw (Self-Tapping) 6.5 x 33 |
| 08800039874960 | Lumbar Plate Variable screw (Self-Tapping) 6.5 x 28 |
| 08800039874946 | Lumbar Plate Variable screw (Self-Tapping) 6.5 x 24 |
| 08800039874922 | Lumbar Plate Variable screw (Self-Tapping) 6.5 x 20 |
| 08800039874663 | Lumbar Plate Variable screw (Self-Tapping) 5.5 x 33 |
| 08800039874649 | Lumbar Plate Variable screw (Self-Tapping) 5.5 x 28 |
| 08800039874625 | Lumbar Plate Variable screw (Self-Tapping) 5.5 x 24 |
| 08800039874601 | Lumbar Plate Variable screw (Self-Tapping) 5.5 x 20 |
| 08800039872423 | Lumbar Plate 1level 25 |
| 08800039872416 | Lumbar Plate 1level 23 |
| 08800039872409 | Lumbar Plate 1level 21 |
| 08800039872393 | Lumbar Plate 1level 19 |
| 08800039872386 | Lumbar Plate 1level 17 |
| 08800039872379 | Lumbar Plate 1level 15 |