AXIUS 8mm Needle Driver - Long

GUDID 00860004002147

FlexDex Surgical

Suturing needle holder, reusable

• Primary Device ID: 00860004002147
• NIH Device Record Key: a03b1333-a558-4689-acc1-5134e15faea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIUS 8mm Needle Driver - Long
• Version Model Number: 8ND1L
• Company DUNS: 967741179
• Company Name: FlexDex Surgical
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004002147 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

[00860004002147]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by FlexDex Surgical

• 00860004002130 - AXIUS 8mm Needle Driver - Medium: 2023-06-26
• 00860004002147 - AXIUS 8mm Needle Driver - Long: 2023-06-26
• 00860004002147 - AXIUS 8mm Needle Driver - Long: 2023-06-26
• 00860004002116 - FlexDex Needle Driver: 2022-08-29