LANCER

GUDID 00840996192927

LANCER,THORACIC,PROBE

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996192927
• NIH Device Record Key: 4b4b4d21-082f-428b-a408-ee0951f9baa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANCER
• Version Model Number: M070-0165
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996192927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171456

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

[00840996192927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [LANCER]

• 00840996192934: LANCER,ILIAC,PROBE
• 00840996192927: LANCER,THORACIC,PROBE
• 00840996192910: LANCER,SHORT LENKE PROBE
• 00840996192903: LANCER,LONG LENKE PROBE
• 00840996192873: LANCER,SLIM COUNTER TORQUE
• 00840996186209: LANCER,NAVIGATION DRIVER,NVL
• 00840996185158: LANCER 9.5MM TAP,GPS NAVIGATION
• 00840996185141: LANCER 8.5MM TAP,GPS NAVIGATION
• 00840996185134: LANCER 7.5MM,TAP,GPS NAVIGATION
• 00840996185127: LANCER 6.5MM,TAP,GPS NAVIGATION
• 00840996185110: LANCER 4.5MM/5.5MM TAP,GPS NAVIGATION
• 00840996185103: LANCER,DRIVER,GPS NAVIGATION
• 00840996185080: Lancer,Tulip Grabber