Native 416.000

GUDID 00850075111091

Spear Passer Needle 5-Pack

INS ORTHO INC.

Suturing unit, single-use

• Primary Device ID: 00850075111091
• NIH Device Record Key: 4814030d-97e8-4a8b-b173-86740cf72630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Native
• Version Model Number: 416.000
• Catalog Number: 416.000
• Company DUNS: 145088199
• Company Name: INS ORTHO INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com
• Phone: 401-400-5742
• Email: complaints@nativeortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850075111091 [Unit of Use]
GS1	00850075111107 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-06
• Device Publish Date: 2026-02-26

On-Brand Devices [Native]

• 00850075111091: Spear Passer Needle 5-Pack
• 00850075111077: Spear Passer Suture Passer
• 00850075111046: Nitinol Wire Loop 5-Pack
• 00850075111039: Nitinol Wire Loop
• 00850075111022: Rake Curette
• 00850075111015: 2.4mm Cannulated Drill
• 00850075111008: Root Finder Guide