Integrity Orthopaedics 901003

GUDID 00860009782228

Integrity Orthopaedics Anchor Array System Kit

Integrity Orthopaedics, Inc

Orthopaedic inorganic implant inserter/extractor, single-use

• Primary Device ID: 00860009782228
• NIH Device Record Key: b7444100-0e96-4a0b-bc50-ccaece3e3386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity Orthopaedics
• Version Model Number: 901003
• Catalog Number: 901003
• Company DUNS: 118804591
• Company Name: Integrity Orthopaedics, 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: true
• 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	00860009782228 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2023-02-13

On-Brand Devices [Integrity Orthopaedics]

• 00860009782228: Integrity Orthopaedics Anchor Array System Kit
• 00860009782211: Integrity Orthopaedics Delivery Instrument, included with Anchor Array System Kit