General 91-7272

GUDID 10889981221393

Malibu Instrument Tray 1 Inner Tray 2

SEASPINE ORTHOPEDICS CORPORATION

Instrument tray, reusable

• Primary Device ID: 10889981221393
• NIH Device Record Key: 60da7e66-7e8a-4283-9448-f3e63336d6d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General
• Version Model Number: 91-7272
• Catalog Number: 91-7272
• 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	10889981221393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122571

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

Moist Heat or Steam Sterilization

[10889981221393]

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