Sniper® Spine System 10-4233

GUDID 10840642130041

Sniper® Tap, 8.0mm, NAV-M

Spine Wave, Inc.

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• Primary Device ID: 10840642130041
• NIH Device Record Key: b0c49769-349f-4c6d-9960-7e69dbc1ea23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sniper® Spine System
• Version Model Number: 10-4233
• Catalog Number: 10-4233
• Company DUNS: 067789763
• Company Name: Spine Wave, 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: 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

• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642130041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181596

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

[10840642130041]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-01-03

On-Brand Devices [Sniper® Spine System]

• 10840642130041: Sniper® Tap, 8.0mm, NAV-M
• 10840642130034: Sniper® Tap, 7.5mm, NAV-M
• 10840642130027: Sniper® Tap, 7.0mm, NAV-M
• 10840642130010: Sniper® Tap, 6.5mm, NAV-M
• 10840642130003: Sniper® Tap, 6.0mm, NAV-M
• 10840642129991: Sniper® Tap, 5.5mm, NAV-M
• 10840642129984: Sniper® Tap, 5.0mm, NAV-M
• 10840642129977: Sniper® Tap, 4.5mm, NAV-M
• 10840642129960: Sniper® Tap, 4.0mm, NAV-M
• 10840642129953: Sniper® XT Screwdriver, NAV-M
• 10840642129946: Sniper® Mini-Open Screwdriver, NAV-M
• 10840642129939: Sniper® Screwdriver, NAV-M
• 10840642119022: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 130 mm
• 10840642119015: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 120 mm
• 10840642119008: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 110 mm
• 10840642118995: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 100 mm
• 10840642118988: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 95 mm
• 10840642118971: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 90 mm
• 10840642118964: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 85 mm
• 10840642118957: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 80 mm
• 10840642118940: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 75 mm
• 10840642118933: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 70 mm
• 10840642118926: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 65 mm
• 10840642118919: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 60 mm
• 10840642118902: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 55 mm
• 10840642118896: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 50 mm
• 10840642118889: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 45 mm
• 10840642118872: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 40 mm
• 10840642118865: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 35 mm
• 10840642118858: Cannulated Pedicle Screw Reduction Tab 10.5 mm x 30 mm
• 10840642118841: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 140 mm
• 10840642118834: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 130 mm
• 10840642118827: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 120 mm
• 10840642118810: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 110 mm
• 10840642118803: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 100 mm
• 10840642118797: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 95 mm
• 10840642118780: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 90 mm
• 10840642118773: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 85 mm
• 10840642118766: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 80 mm
• 10840642118759: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 75 mm
• 10840642118742: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 70 mm
• 10840642118735: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 65 mm
• 10840642118728: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 60 mm
• 10840642118711: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 55 mm
• 10840642118704: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 50 mm
• 10840642118698: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 45 mm
• 10840642118681: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 40 mm
• 10840642118674: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 35 mm
• 10840642118667: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 30 mm
• 10840642118650: Cannulated Pedicle Screw Reduction Tab 8.5 mm x 140 mm