Mediflex Medi-Clip 50120-ML

GUDID 30842102105013

Medium Large Clips - 1 Cartridge/1 Pouch

FLEXBAR MACHINE CORPORATION

Ligation clip, metallic

• Primary Device ID: 30842102105013
• NIH Device Record Key: b197d6af-7220-4dd5-a574-6f3241593612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediflex Medi-Clip
• Version Model Number: 50120-ML
• Catalog Number: 50120-ML
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10842102105019 [Primary]
GS1	20842102105016 [Package]; Contains: 10842102105019; Package: Case [20 Units]; In Commercial Distribution
GS1	30842102105013 [Package]; Contains: 20842102105016; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091060

FDA Product Code

• FZP: Clip, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2017-05-12

On-Brand Devices [Mediflex Medi-Clip ]

• 00842102111655: 10mm x 45cm Clip Applier for Medium Large Clip
• 30842102105013: Medium Large Clips - 1 Cartridge/1 Pouch