DKWA Tear Drop Handle, Coupling Connection

GUDID 07290115935189

PREMIA SPINE LTD

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 07290115935189
• NIH Device Record Key: 7c21349c-4c49-4a91-a956-ca5b52f10ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DKWA Tear Drop Handle, Coupling Connection
• Version Model Number: 88169
• Company DUNS: 649220779
• Company Name: PREMIA SPINE LTD
• 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	07290115935189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150380
• Premarket Approval: P220002

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System
• QWK: Prosthesis, Posterior Spinal Elements

Sterilization

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

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

[07290115935189]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

Devices Manufactured by PREMIA SPINE LTD

• 07290115935264 - PER System 60: 2024-10-18 PER System 60
• 07290115935271 - PER System 75: 2024-10-18 PER System 75
• 07290115935332 - PER System 50: 2024-10-18 PER System 50
• 07290115935561 - Distractor: 2024-10-18
• 07290115931808 - Ring Nut Inserter: 2024-10-09
• 07290115932485 - Ring Nut Loading Base: 2024-10-09
• 07290115932515 - Versalink Nut Counter Torque: 2024-10-09
• 07290115932553 - VersaLink Bender: 2024-10-09