Calibrate
GUDID 00190376538822
LIF Calibrate LTX and AMP-LTX Instruments
ALPHATEC SPINE, INC.
Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| Primary Device ID | 00190376538822 |
| NIH Device Record Key | e11dcb6b-226d-45c4-b21a-38975b908f17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calibrate |
| Version Model Number | LTXINS |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00190376538822 [Primary] |
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
[00190376538822]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-04 |
| Device Publish Date | 2024-02-23 |
On-Brand Devices [Calibrate]
| 00190376474786 | LTX REMOVAL TOOL |
| 00190376474779 | LTX EXPANSION DRIVER AXIAL, 26 in-lbs |
| 00190376474762 | LTX EXPANSION DRIVER T-HANDLE, 26 in-lbs |
| 00190376474205 | LTX TRIAL, 6 x 22 x 60 mm, 20° |
| 00190376474199 | LTX TRIAL, 6 x 22 x 60 mm, 15° |
| 00190376473994 | LTX SPACER, 6 x 22 x 60 mm, 20° |
| 00190376473987 | LTX SPACER, 6 x 22 x 60 mm, 15° |
| 00190376473963 | LTX SPACER, 6 x 22 x 55 mm, 20° |
| 00190376473956 | LTX SPACER, 6 x 22 x 55 mm, 15° |
| 00190376473932 | LTX SPACER, 6 x 22 x 50 mm, 20° |
| 00190376473925 | LTX SPACER, 6 x 22 x 50 mm, 15° |
| 00190376473901 | LTX SPACER, 6 x 22 x 45 mm, 20° |
| 00190376473895 | LTX SPACER, 6 x 22 x 45 mm, 15° |
| 00190376473888 | LTX SPACER, 6 x 18 x 60 mm, 20° |
| 00190376473871 | LTX SPACER, 6 x 18 x 60 mm, 15° |
| 00190376473864 | LTX SPACER, 6 x 18 x 55 mm, 20° |
| 00190376473857 | LTX SPACER, 6 x 18 x 55 mm, 15° |
| 00190376473840 | LTX SPACER, 6 x 18 x 50 mm, 20° |
| 00190376473833 | LTX SPACER, 6 x 18 x 50 mm, 15° |
| 00190376473826 | LTX SPACER, 6 x 18 x 45 mm, 20° |
| 00190376473819 | LTX SPACER, 6 x 18 x 45 mm, 15° |
| 00190376472218 | LTX GRAFT TUBE |
| 00190376472201 | LTX GRAFT TAMP |
| 00190376472195 | LTX GRAFT FUNNEL |
| 00190376472164 | LTX ATTACHMENT DRIVER |
| 00190376472157 | LTX Freehand Expansion Driver |
| 00190376472140 | LTX ANGLED INSERTER, OFFSET LEFT |
| 00190376472133 | LTX ANGLED INSERTER, OFFSET RIGHT |
| 00190376472089 | LTX INSERTER |
| 00190376472072 | LTX TRIAL, 6 x 22 x 60 mm, 30° |
| 00190376472065 | LTX TRIAL, 6 x 18 x 60 mm, 20° |
| 00190376472058 | LTX TRIAL, 6 x 18 x 60 mm, 15° |
| 00190376474182 | LTX Bone Screw, Ø5.5 mm x 60 mm |
| 00190376474175 | LTX Bone Screw, Ø5.5 mm x 55 mm |
| 00190376474168 | LTX Bone Screw, Ø5.5 mm x 50 mm |
| 00190376474151 | LTX Bone Screw, Ø5.5 mm x 45 mm |
| 00190376474144 | LTX Bone Screw, Ø5.5 mm x 40 mm |
| 00190376474137 | LTX Bone Screw, Ø5.5 mm x 35 mm |
| 00190376474120 | LTX Bone Screw, Ø5.5 mm x 30 mm |
| 00190376474113 | LTX Bone Screw, Ø5.5 mm x 25 mm |
| 00190376474106 | LTX Bone Screw, Ø5.0 mm x 60 mm |
| 00190376474090 | LTX Bone Screw, Ø5.0 mm x 55 mm |
| 00190376474083 | LTX Bone Screw, Ø5.0 mm x 50 mm |
| 00190376474076 | LTX Bone Screw, Ø5.0 mm x 45 mm |
| 00190376474069 | LTX Bone Screw, Ø5.0 mm x 40 mm |
| 00190376474052 | LTX Bone Screw, Ø5.0 mm x 35 mm |
| 00190376474045 | LTX Bone Screw, Ø5.0 mm x 30 mm |
| 00190376474038 | LTX Bone Screw, Ø5.0 mm x 25 mm |
| 00190376474007 | LTX HL SPACER, 6 x 22 x 60 mm, 30° |
| 00190376473970 | LTX HL SPACER, 6 x 22 x 55 mm, 30° |
Trademark Results [Calibrate]
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