TRYPTIK INSTRUMENTATION MOS-IN 14 05-N

GUDID 07640139340665

Trial D14H5

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640139340665
• NIH Device Record Key: 7d3e2aaf-0d1d-405a-8896-d2a552b7a81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRYPTIK INSTRUMENTATION
• Version Model Number: MOS-IN 14 05-N
• Catalog Number: MOS-IN 14 05-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: true
• 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	07640139340665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091873

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

[07640139340665]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-27

On-Brand Devices [TRYPTIK INSTRUMENTATION]

• 07640139349330: REVISION SCREWDRIVER
• 07640139340719: FULL SET INCLUDING TRYPTIK CA INSTRUMENTS
• 07640139340702: EMPTY INSTRUMENTS TRAY
• 07640139340696: Trial D14H8
• 07640139340689: Trial D14H7
• 07640139340672: Trial D14H6
• 07640139340665: Trial D14H5
• 07640139340658: Trial D12H7
• 07640139340641: Trial D12H6
• 07640139340634: Trial D12H5
• 07640139340610: PLATE EXTRACTOR
• 07640139340603: PLATE BENDER
• 07640139340597: Compactor base
• 07640139340580: Compactor
• 07640139340573: SCREWDRIVER 2.5
• 07640139340566: MOS-IN 00 02-N
• 07640139340559: BONE AWL
• 07640178989863: TRAY FOR NON STERILE IMPLANTS
• 07640178989832: TRAY FOR NON STERILE IMPLANTS
• 07640178989818: TRAY FOR NON STERILE IMPLANTS
• 07640450865649: ANATOMIC RASP TRIAL RACK (TRYPTIK® Ti)
• 07640450865632: CERVICAL DISTRACTOR LID (TRYPTIK® Ti)
• 07640450865625: TRYPTIK Ti LID (TRYPTIK® Ti)