Sigma
GUDID 00190376394640
TERTIARY DILATOR, ELLIPTICAL
ALPHATEC SPINE, INC.
Neurophysiologic monitoring system| Primary Device ID | 00190376394640 |
| NIH Device Record Key | 40f17be7-393f-4567-a237-f249f6368593 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sigma |
| Version Model Number | 250-050 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376394640 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191723
FDA Product Code
| ETN | STIMULATOR, NERVE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
[00190376394640]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-03 |
| Device Publish Date | 2022-01-26 |
On-Brand Devices [Sigma]
| 00190376276311 | Sigma TLIF Access System |
| 00190376276267 | Sigma TLIF A-Arm |
| 00190376279169 | LATERAL ARM, RIGHT |
| 00190376279152 | LATERAL ARM, LEFT |
| 00190376270784 | SMALL MEDIAL BLADE, SIGMA |
| 00190376270777 | 120mm C-C BLADE, SIGMA |
| 00190376270760 | 110mm C-C BLADE, SIGMA |
| 00190376270753 | 100mm C-C BLADE, SIGMA |
| 00190376270746 | 90mm C-C BLADE, SIGMA |
| 00190376270739 | 80mm C-C BLADE, SIGMA |
| 00190376270722 | 70mm C-C BLADE, SIGMA |
| 00190376270715 | 60mm C-C BLADE, SIGMA |
| 00190376270708 | 50mm C-C BLADE, SIGMA |
| 00190376270692 | XL MEDIAL BLADE, SIGMA |
| 00190376270685 | LARGE MEDIAL BLADE, SIGMA |
| 00190376270678 | MEDIUM MEDIAL BLADE, SIGMA |
| 00190376270166 | SIGMA RETRACTOR |
| 00190376270142 | COBB, SIGMA |
| 00190376270135 | SPLAY KNOB DRIVER, SIGMA |
| 00190376270128 | ACCESS HEX DRIVER, T-HANDLE, SIGMA |
| 00190376270111 | T25 BALL-HEX DRIVER, IN-LINE, SIGMA |
| 00190376270104 | MEDIAL BLADE INSERTER, SIGMA |
| 00190376316604 | 120mm C-C Blade, Sigma TLIF |
| 00190376316598 | 110mm C-C Blade, Sigma TLIF |
| 00190376316581 | 100mm C-C Blade, Sigma TLIF |
| 00190376316574 | 90mm C-C Blade, Sigma TLIF |
| 00190376316567 | 80mm C-C Blade, Sigma TLIF |
| 00190376316550 | 70mm C-C Blade, Sigma TLIF |
| 00190376316543 | 60mm C-C Blade, Sigma TLIF |
| 00190376316536 | 50mm C-C Blade, Sigma TLIF |
| 00190376330716 | RIGHT EXPOSURE GUARD, LONG, SIGMA TLIF ACCESS |
| 00190376330709 | LEFT EXPOSURE GUARD, LONG, SIGMA TLIF ACCESS |
| 00190376330693 | RIGHT EXPOSURE GUARD, SHORT, SIGMA TLIF ACCESS |
| 00190376330686 | LEFT EXPOSURE GUARD, SHORT, SIGMA TLIF ACCESS |
| 00190376330679 | ILLUMINATION GUIDE, SIGMA TLIF ACCESS |
| 00190376330662 | BLADE WING, RIGHT, SIGMA TLIF |
| 00190376330655 | BLADE WING, LEFT, SIGMA TLIF |
| 00190376397153 | SIGMA LTP BLADE EXTENDER, WIDE, 30mm |
| 00190376397146 | SIGMA LTP BLADE EXTENDER, WIDE, 28mm |
| 00190376397139 | SIGMA LTP BLADE EXTENDER, WIDE, 26mm |
| 00190376397122 | SIGMA LTP BLADE EXTENDER, NARROW, 30mm |
| 00190376397115 | SIGMA LTP BLADE EXTENDER, NARROW, 28mm |
| 00190376397108 | SIGMA LTP BLADE EXTENDER, NARROW, 26mm |
| 00190376397092 | SIGMA LTP INTRADISCAL SHIM, WIDE |
| 00190376397085 | SIGMA LTP INTRADISCAL SHIM, NARROW |
| 00190376395272 | SIGMA LTP CROSS BAR |
| 00190376394671 | INLINE A-ARM EXTENSION |
| 00190376394664 | SIGMA LTP STEERING HANDLE |
| 00190376394640 | TERTIARY DILATOR, ELLIPTICAL |
| 00190376394527 | SIGMA LTP ALL RETRACTOR, 230mm |
Trademark Results [Sigma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGMA 98886118 not registered Live/Pending |
Jeffery Lerma 2024-12-05 |
 SIGMA 98877293 not registered Live/Pending |
Princess Yachts Limited 2024-11-28 |
 SIGMA 98752620 not registered Live/Pending |
Dennis Productions LLC 2024-09-16 |
 SIGMA 98600151 not registered Live/Pending |
Gorilla Mind, LLC 2024-06-13 |
 SIGMA 98323514 not registered Live/Pending |
Frictionless Systems, LLC 2023-12-20 |
 SIGMA 98323406 not registered Live/Pending |
Frictionless Systems, LLC 2023-12-20 |
 SIGMA 98126485 not registered Live/Pending |
Ascend Eagle Inc 2023-08-10 |
 SIGMA 98063569 not registered Live/Pending |
SIGMA Assessment Systems, Inc. 2023-06-28 |
 SIGMA 98010241 not registered Live/Pending |
Worthington Cylinder Corporation 2023-05-23 |
 SIGMA 98010228 not registered Live/Pending |
Worthington Cylinder Corporation 2023-05-23 |
 SIGMA 97918591 not registered Live/Pending |
Sigma Instruments Holdings, LLC 2023-05-03 |
 SIGMA 97627844 not registered Live/Pending |
Sigma Components Ltd. 2022-10-11 |
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