Romero Large Introducer for Extended Heights RO0006LIEH

GUDID B806RO0006LIEH0

Romero Large Introducer for Extended Heights (H is greater than or equal to 10)

Spineup, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B806RO0006LIEH0
• NIH Device Record Key: 14ce7488-2a3e-4050-b623-9fc35ab54b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Romero Large Introducer for Extended Heights
• Version Model Number: RO0006LIEH
• Catalog Number: RO0006LIEH
• Company DUNS: 116999578
• Company Name: Spineup, Inc.
• 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

Customer Support Contacts

• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech
• Phone: 786-910-0234
• Email: contact@upgroup.tech

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B806RO0006LIEH0 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

[B806RO0006LIEH0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-22
• Device Publish Date: 2024-10-14

Devices Manufactured by Spineup, Inc.

• B806RO0015QCAZ0 - Quick Connect Awl: 2025-03-04 Quick Connect Aw
• B806RO1877AF1118X140 - Anatomic Rasp with Stop 18x14, H11mm: 2025-03-04 Anatomic Rasp with Stop 18x14, H11mm
• B806GN0001SSMZ0 - Small Slotted Mallet: 2024-10-22 Small Slotted Mallet
• B806GN0004SAQC0 - Small AO Quick Connect Handle: 2024-10-22 Small AO Quick Connect Handle
• B806GN0005MAQC0 - Medium AO Quick Connect Handle: 2024-10-22 Medium AO Quick Connect Handle
• B806GN0006LAQC0 - Large AO Quick Connect Handle: 2024-10-22 Large AO Quick Connect Handle
• B806GN0010SRZZ0 - Romero Cervical Screw Remover: 2024-10-22 Cervical Screw Remover
• B806GN0011T08S0 - Cervical Screw Driver Shaft Straight Quick Connect: 2024-10-22 Cervical Screw Driver Shaft Straight Quick Connect