Constrictor® Mini Button Extender AB-3150NS

GUDID 00854629006765

Mini Extended Button to be used with Constrictor® Mini (Non-Sterile)

DUNAMIS MEDICAL, LLC

Orthopaedic bone washer, non-sterile

• Primary Device ID: 00854629006765
• NIH Device Record Key: bb353111-eacc-4b73-8d95-ff2246dcce93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constrictor® Mini Button Extender
• Version Model Number: AB-3150NS
• Catalog Number: AB-3150NS
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• 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: 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	00854629006765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191319

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

[00854629006765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [Constrictor® Mini Button Extender]

• 00854629006765: Mini Extended Button to be used with Constrictor® Mini (Non-Sterile)
• 00854629006758: Mini Extended Button to be used with Constrictor® Mini (AB-3000)