PASS TULIP

GUDID 03613720272885

CLOSED/CLOSED DOMINO - 12 mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720272885
• NIH Device Record Key: d4e25d4c-bb1c-48e4-b4ed-7f7f5f125a3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASS TULIP
• Version Model Number: B22066412
• 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	03613720272885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182240

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03613720272885]

Moist Heat or Steam Sterilization

[03613720272885]

Moist Heat or Steam Sterilization

[03613720272885]

Moist Heat or Steam Sterilization

[03613720272885]

Moist Heat or Steam Sterilization

[03613720272885]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-05-23
• Device Publish Date: 2018-10-30

On-Brand Devices [PASS TULIP]

• 03613720274469: SCREW REMOVER
• 03613720272830: OPEN/OPEN DOMINO - 12 mm
• 03613720274704: 25mm reducer, long
• 03613720274667: CLOSED ILIAC CONNECTOR - 50 mm
• 03613720274650: CLOSED ILIAC CONNECTOR - 25 mm
• 03613720274643: OPEN ILIAC CONNECTOR - 50 mm
• 03613720274636: OPEN ILIAC CONNECTOR - 25 mm
• 03613720273011: CLOSED ILIAC CONNECTOR - 60 mm
• 03613720273004: OPEN ILIAC CONNECTOR - 60 mm
• 03613720272885: CLOSED/CLOSED DOMINO - 12 mm
• 03613720272878: CLOSED/CLOSED DOMINO - 17 mm
• 03613720272861: OPEN/CLOSED DOMINO - 17 mm
• 03613720272854: OPEN/CLOSED DOMINO - 12 mm
• 03613720272847: OPEN/OPEN DOMINO - 17 mm
• 03613720272823: CLOSED ILIAC CONNECTOR - 30 mm
• 03613720272816: CLOSED ILIAC CONNECTOR - 100 mm
• 03613720272809: OPEN ILIAC CONNECTOR - 100 mm
• 03613720272793: OPEN ILIAC CONNECTOR - 30 mm