| Primary Device ID | 03661380009051 |
| NIH Device Record Key | 10112abd-66ab-4eab-be81-ea14016ec2e2 |
| Commercial Distribution Discontinuation | 2023-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Isobar |
| Version Model Number | 12VDHS80-35 |
| Company DUNS | 502816283 |
| Company Name | SCIENT'X |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com | |
| Phone | +1(760)494-6840 |
| mfunk@alphatecspine.com |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661380009051 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
[03661380009051]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2015-09-10 |