Dymaxeon 06.2330
GUDID 00815500025145
DYMAXEON 6.0 MONOAXIAL PEDICLE SCREW Ø5.5 x 30mm (BLUE)
BACK 2 BASIC DIRECT, LLC
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00815500025145 |
| NIH Device Record Key | ccbcf631-a959-4bfc-a442-060f519d4b72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dymaxeon |
| Version Model Number | 06.0 |
| Catalog Number | 06.2330 |
| Company DUNS | 043841348 |
| Company Name | BACK 2 BASIC DIRECT, LLC |
| Device Count | 2 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com | |
| Phone | 216-447-5025 |
| info@back2basicsdirect.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815500025145 [Primary] |
| GS1 | 10815500025142 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121786
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-12 |
| Device Publish Date | 2019-03-04 |
On-Brand Devices [Dymaxeon]
| 00815500024261 | DYMAXEON CURVED ROD SIZE Ø5.5 X 90mm (YELLOW) |
| 00815500024254 | DYMAXEON CURVED ROD SIZE Ø5.5 X 80mm (YELLOW) |
| 00815500024247 | DYMAXEON CURVED ROD SIZE Ø5.5 X 75mm (YELLOW) |
| 00815500024230 | DYMAXEON CURVED ROD SIZE Ø5.5 X 70mm (YELLOW) |
| 00815500024223 | DYMAXEON CURVED ROD SIZE Ø5.5 X 65mm (YELLOW) |
| 00815500024216 | DYMAXEON CURVED ROD SIZE Ø5.5 X 60mm (YELLOW) |
| 00815500024209 | DYMAXEON CURVED ROD SIZE Ø5.5 X 55mm (YELLOW) |
| 00815500024193 | DYMAXEON CURVED ROD SIZE Ø5.5 X 50mm (YELLOW) |
| 00815500024186 | DYMAXEON CURVED ROD SIZE Ø5.5 X 45mm (YELLOW) |
| 00815500024179 | DYMAXEON CURVED ROD SIZE Ø5.5 X 40mm (YELLOW) |
| 00815500024162 | DYMAXEON CURVED ROD SIZE Ø5.5 X 35mm (YELLOW) |
| 00815500024155 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 400mm (GREEN) |
| 00815500024148 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 350mm (BLUE) |
| 00815500024131 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 300mm (BLUE) |
| 00815500024124 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 250mm (YELLOW) |
| 00815500024117 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 200mm (YELLOW) |
| 00815500024100 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 150mm (VIOLET) |
| 00815500024094 | DYMAXEON STRAIGHT ROD SIZE Ø5.5 X 100mm (VIOLET) |
| 00815500024087 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 70mm (GREEN) |
| 00815500024070 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 50mm (GREEN) |
| 00815500024063 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 45mm (GREEN) |
| 00815500024056 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 40mm (GREEN) |
| 00815500024049 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 50mm (BLUE) |
| 00815500024032 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 45mm (BLUE) |
| 00815500024025 | DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 40mm (BLUE) |
| 00815500024018 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 90mm (YELLOW) |
| 00815500024001 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 80mm (YELLOW) |
| 00815500023998 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 70mm (YELLOW) |
| 00815500023981 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 60mm (YELLOW) |
| 00815500023974 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 55mm (YELLOW) |
| 00815500023967 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 50mm (YELLOW) |
| 00815500023950 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 45mm (YELLOW) |
| 00815500023943 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 40mm (YELLOW) |
| 00815500023936 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 90mm (VIOLET) |
| 00815500023929 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 80mm (VIOLET) |
| 00815500023912 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 70mm (VIOLET) |
| 00815500023905 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 60mm (VIOLET) |
| 00815500023899 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 55mm (VIOLET) |
| 00815500023882 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 50mm (VIOLET) |
| 00815500023875 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 45mm (VIOLET) |
| 00815500023868 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 40mm (VIOLET) |
| 00815500023851 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø7.5 x 35mm (VIOLET) |
| 00815500023844 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 55mm (GREEN) |
| 00815500023837 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 50mm (GREEN) |
| 00815500023820 | Dymaxeon Pedicle Screw - Cap Include 6.5 x 45mm (Green) |
| 00815500023813 | Dymaxeon Pedicle Screw - Cap Include 6.5 x 40mm (Green) |
| 00815500023806 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 35mm (GREEN) |
| 00815500023790 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 70mm (BLUE) |
| 00815500023783 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 65mm (BLUE) |
| 00815500023776 | DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø5.5 x 60mm (BLUE) |
Trademark Results [Dymaxeon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYMAXEON 86561740 4869761 Live/Registered |
BACK 2 BASICS DIRECT, LLC 2015-03-12 |
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