| Primary Device ID | 00840311238231 |
| NIH Device Record Key | f81f8003-9f26-43c5-b1a1-a76c72dc676b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline OCT |
| Version Model Number | 26-H2H-XLINK-XXL |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, Inc. |
| 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 | 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(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com | |
| Phone | +1(844)894-7752 |
| customerservice@surgalign.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311238231 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
[00840311238231]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
| 00840311242733 | CERVICAL MODULAR HANDLE |
| 00840311240920 | STREAMLINE OCT, RIGID SCREW INSERTER |
| 00840311240791 | Yoke Manipulator, Slim |
| 00840311240784 | YOKE MANIPULATOR |
| 00840311240777 | YOKE MANIPULATOR |
| 00840311240760 | Variable Drill Guide |
| 00840311240753 | Variable Drill Guide |
| 00840311240746 | Variable Drill, Ø2.0mm |
| 00840311240739 | OCT Torque Limiting Handle |
| 00840311240586 | Pedicle Finder, Straight |
| 00840311240579 | Set Screw |
| 00840311240562 | Passive Locking Inserter |
| 00840311240555 | SCREW INSERTER |
| 00840311240548 | SCREW INSERTER |
| 00840311240531 | ROD TEMPLATE |
| 00840311240524 | Rod Template, 240mm |
| 00840311240517 | Rod Template, 120mm |
| 00840311240500 | ROD TEMPLATE |
| 00840311240494 | Rod Cutter, Dual |
| 00840311240487 | ROD CUTTER |
| 00840311240470 | ROD CUTTER |
| 00840311240463 | Rod Rocker |
| 00840311240456 | ROCKER REDUCER |
| 00840311240449 | Rod Reducer |
| 00840311240432 | ROD REDUCER |
| 00840311240425 | Rod Reducer |
| 00840311240418 | AO Ratchet Handle |
| 00840311240401 | ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE |
| 00840311240395 | ROD-TO-ROD CROSSLINK, EXTRA-LARGE |
| 00840311240388 | Rod-to-Rod Crosslink - S, 26-34mm |
| 00840311240371 | Rod-to-Rod Crosslink - M, 32-40mm |
| 00840311240364 | Rod-to-Rod Crosslink - L, 38-46mm |
| 00840311240357 | Final Driver, Rod-to-Rod Crosslink |
| 00840311240340 | Palm Handle, OCP |
| 00840311240326 | Polyaxial Screw, Smooth Shank, 4.0 X 48mm |
| 00840311240319 | Polyaxial Screw, Smooth Shank, 4.0 X 46mm |
| 00840311240302 | Polyaxial Screw, Smooth Shank, 4.0 X 44mm |
| 00840311240296 | Polyaxial Screw, Smooth Shank, 4.0 X 42mm |
| 00840311240289 | Polyaxial Screw, Smooth Shank, 4.0 X 40mm |
| 00840311240272 | Polyaxial Screw, Smooth Shank, 4.0 X 38mm |
| 00840311240265 | Polyaxial Screw, Smooth Shank, 4.0 X 36mm |
| 00840311240258 | Polyaxial Screw, Smooth Shank, 4.0 X 34mm |
| 00840311240241 | Polyaxial Screw, Smooth Shank, 4.0 X 32mm |
| 00840311240234 | Polyaxial Screw, Smooth Shank, 4.0 X 30mm |
| 00840311240227 | Polyaxial Screw, Smooth Shank, 4.0 X 28mm |
| 00840311240210 | Polyaxial Screw, Smooth Shank, 4.0 X 26mm |
| 00840311240203 | Polyaxial Screw, Smooth Shank, 4.0 X 24mm |
| 00840311240197 | Polyaxial Screw, Smooth Shank, 4.0 X 22mm |
| 00840311240180 | Polyaxial Screw, Smooth Shank, 4.0 X 20mm |
| 00840311240173 | Polyaxial Screw, Smooth Shank, 3.5 X 48mm |