Swiveling Sleeve

GUDID 07290115935158

PREMIA SPINE LTD

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 07290115935158
• NIH Device Record Key: 567b6bb3-5919-4377-b8ae-50b3ae82f321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swiveling Sleeve
• Version Model Number: 88107
• 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	07290115935158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150380

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

[07290115935158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01

Devices Manufactured by PREMIA SPINE LTD

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• 07290115934816 - K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA: 2025-09-17
• 07290014381148 - SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill: 2025-09-16
• 07290014381155 - SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique: 2025-09-16
• 07290014381162 - SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire: 2025-09-16
• 07290014381186 - SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked): 2025-09-16
• 07290014381193 - SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-Wire: 2025-09-16
• 07290014381209 - SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-Wire: 2025-09-16