General 91-7298

GUDID 10889981247805

NewPort Implant Tray, Level 1

SEASPINE ORTHOPEDICS CORPORATION

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: 10889981247805
• NIH Device Record Key: b755570d-4485-4a61-9979-0f9a2caba13e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General
• Version Model Number: 91-7298
• Catalog Number: 91-7298
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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	10889981247805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180176

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

[10889981247805]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

On-Brand Devices [General]

• 10889981144296: Palm Style Probe
• 10889981144265: 3.5mm Tap File
• 10889981143497: Dilator 5 Threaded File
• 10889981140267: Locking Driver, Free Sleeve
• 10889981159474: TruProfile Plate Caddy
• 10889981143343: Slap Hammer, 3/8 Male
• 10889981289362: Suction Tip, #10
• 10889981289355: Suction Tip, #8
• 10889981286934: Alpha Universal Lid, 20 X 10
• 10889981325107: Meridian 4-Hole No-Profile Instrument Tray Level 1
• 10889981325091: Meridian 4-Hole No-Profile Instrument Tray Case
• 10889981310240: Meridian Trial Rasp Tray
• 10889981308896: Lattus Tray - Top Level
• 10889981308889: Lattus Tray - Base Level
• 10889981300357: MIS Retractor Tray Level 2
• 10889981300340: MIS Retractor Tray Level 1
• 10889981300333: MIS Retractor Tray Case
• 10889981300142: Mariner RDX MIS Tray
• 10889981296988: Mariner Deformity Rod Tray
• 10889981296827: Mariner Deformity Uni-Axial Screw Tray Base
• 10889981296803: Mariner Deformity Uni-Planar Screw Tray Base
• 10889981296667: Mariner Deformity Implant Tray Bottom Insert
• 10889981296650: Mariner Deformity Implant Tray Top Insert
• 10889981296643: Mariner Deformity Implant Tray Base
• 10889981291273: Manta Ray TDF Tray
• 10889981289263: BOTTOM TRAY
• 10889981286033: Facet Prep Instrumentation Tray ? Lid, Lumbar
• 10889981286026: Facet Prep Instrumentation Tray ? Base, Lumbar
• 10889981277574: ACP Tray Case, ASC
• 10889981277444: ACP Misc Tray (4/5 Level Plate & Misc Tray)
• 10889981277437: ACP Implant Tray (Plate & Screw Tray)
• 10889981277420: ACP Fixation Tray (Prep & Insertion Tray)
• 10889981276461: Shoreline TruProfile Plate Tray
• 10889981276140: NewPort Instrument Tray 2, Level 2
• 10889981276133: NewPort Instrument Tray 2
• 10889981260170: NewPort Implant Tray, Level 2
• 10889981260163: NewPort Instrument Tray 1
• 10889981260156: Navigation Tray Insert
• 10889981260149: Navigation Tray Case
• 10889981255633: Daytona Auxiliary Tray
• 10889981247805: NewPort Implant Tray, Level 1
• 10889981247799: NewPort Implant Tray
• 10889981247782: Malibu 8.0+ Instrument Tray
• 10889981247768: NewPort Instrument Tray 2, Level 1
• 10889981247751: Malibu Hook Instrument Tray
• 10889981221508: NewPort Instrument Tray 1, Level 2
• 10889981221492: Inner Tray Lid
• 10889981221485: Malibu Implant Tray Lid
• 10889981221478: Malibu Implant Tray 1 Inner Tray 2
• 10889981221461: Malibu Implant Tray 1 Inner Tray 1