Simplify

GUDID 00843285101020

Simplify Housing Assembly

Nuvasive, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00843285101020
• NIH Device Record Key: 7d354e11-0c6f-48f1-86eb-ba23fefde66d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplify
• Version Model Number: CR-A
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843285101020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200022

FDA Product Code

• MJO: Prosthesis, intervertebral disc

Sterilization

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

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

[00843285101020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [Simplify]

• 00843285102188: Simplify Disc Size 3, Ht 6, 5°
• 00843285102171: Simplify Disc – Size 3, Height 6, 5°
• 00843285102164: Simplify Disc Size 3, Ht 6
• 00843285102157: Simplify Disc – Size 3, Height 6
• 00843285102140: Simplify Disc Size 3, Ht 5, 5°
• 00843285102133: Simplify Disc – Size 3, Height 5, 5°
• 00843285102126: Simplify Disc Size 3, Ht 5
• 00843285102119: Simplify Disc – Size 3, Height 5
• 00843285102041: Simplify Disc Size 2, Ht 6, 5°
• 00843285102034: Simplify Disc – Size 2, Height 6, 5°
• 00843285102027: Simplify Disc Size 2, Ht 6
• 00843285102010: Simplify Disc – Size 2, Height 6
• 00843285102003: Simplify Disc Size 2, Ht 5, 5°
• 00843285101990: Simplify Disc – Size 2, Height 5, 5°
• 00843285101983: Simplify Disc Size 2, Ht 5
• 00843285101976: Simplify Disc – Size 2, Height 5
• 00843285101969: Simplify Disc Size 2, Ht 4
• 00843285101952: Simplify Disc – Size 2, Height 4
• 00843285101938: Simplify Disc Size 1, Ht 6
• 00843285101921: Simplify Disc Size 1, Ht 5
• 00843285101914: Simplify Disc – Size 1, Height 5
• 00843285101907: Simplify Disc Size 1, Ht 5, 5°
• 00843285101891: Simplify Disc Size 1, Ht 5
• 00843285101884: Simplify Disc Size 1, Ht 4, 5°
• 00843285101877: Simplify Disc Size 1, Ht 4
• 00843285101778: Simplify Intervertebral Distractor
• 00843285101761: Simplify Tamp
• 00843285101723: Simplify Slot Cutter, 5-6mm Size Large
• 00843285101716: Simplify Slot Cutter, 5-6mm Size Medium
• 00843285101044: Simplify Osteotome
• 00843285101037: Simplify Core Gauge
• 00843285101020: Simplify Housing Assembly
• 00843285101013: Simplify Core Removal Handle
• 00843285101006: Simplify Shaft, Internal Assembly Small
• 00843285100993: Simplify Shaft, Internal Assembly Large
• 00843285100924: Simplify Adjustable Stop
• 00843285100894: Simplify Slide Hammer
• 00195377105547: Simplify Paddle Distractor
• 00195377105530: Simplify Disc Size 3, Ht 6, 5°
• 00195377105523: Simplify Disc Size 3, Ht 6
• 00195377105516: Simplify Disc Size 3, Ht 5, 5°
• 00195377105509: Simplify Disc Size 3, Ht 5
• 00195377105493: Simplify Disc Size 2, Ht 6, 5°
• 00195377105486: Simplify Disc Size 2, Ht 6
• 00195377105479: Simplify Disc Size 2, Ht 5, 5°
• 00195377105462: Simplify Disc Size 2, Ht 5
• 00195377105455: Simplify Disc Size 2, Ht 4
• 00195377105448: Simplify Disc Size 1, Ht 6
• 00195377105431: Simplify Disc Size 1, Ht 5, 5°
• 00195377105424: Simplify Disc Size 1, Ht 5