PASSLP

GUDID 03613720253358

ILIAC CANNULATED SCREW Ø9,5 mm x 85 mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720253358
• NIH Device Record Key: a6c1db4b-17a0-46ec-b46a-4b55b20ffadc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASSLP
• Version Model Number: B22039585
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	03613720253358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161627

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

[03613720253358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-14
• Device Publish Date: 2018-09-14

Devices Manufactured by MEDICREA INTERNATIONAL

• 03613720286714 - IB3D™ PL Spinal System: 2025-03-04 PUSHER A24000230 IB3D IMPLANT PUSHER
• 03613720286677 - IB3D™ PL Spinal System: 2025-03-03 INSERTER A24000000 IB3D IMPLANT
• 03613720286684 - IB3D™ PL Spinal System: 2025-03-03 SLAPHAMMER A24000200 IB3D SLAP HAMMER
• 03613720286707 - IB3D™ PL Spinal System: 2025-03-03 REMOVER A24000220 IB3D IMPLANT REMOVER
• 03613720286202 - IB3D™ PL Spinal System: 2025-02-24 CAGE B241C08062209 3D PL 8X6DGX22X9MM
• 03613720286219 - IB3D™ PL Spinal System: 2025-02-24 CAGE B241C09062209 3D PL 9X6DGX22X9MM
• 03613720286226 - IB3D™ PL Spinal System: 2025-02-24 CAGE B241C10062209 3D PL 10X6DGX22X9MM
• 03613720286233 - IB3D™ PL Spinal System: 2025-02-24 CAGE B241C11062209 3D PL 11X6DGX22X9MM