MynxGrip Vascular Closure Device (5F) MX5021

GUDID M465MX50210

MynxGrip Vascular Closure Device (5F)

Access Closure, Inc.

Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: M465MX50210
• NIH Device Record Key: 8d9bb1b0-85be-4267-a4ef-71eef35a91ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MynxGrip Vascular Closure Device (5F)
• Version Model Number: MX5021
• Catalog Number: MX5021
• Company DUNS: 132286761
• Company Name: Access Closure, 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

Customer Support Contacts

• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: 877-700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com
• Phone: +1(877)700-6969
• Email: customerservice@accessclosure.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M465MX50210 [Primary]
HIBCC	M465MX50211 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040044

FDA Product Code

• MGB: Device, Hemostasis, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-02-15
• Device Publish Date: 2017-02-06

Devices Manufactured by Access Closure, Inc.

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• M465MX50210 - MynxGrip Vascular Closure Device (5F): 2022-02-15MynxGrip Vascular Closure Device (5F)
• M465MX50210 - MynxGrip Vascular Closure Device (5F): 2022-02-15 MynxGrip Vascular Closure Device (5F)
• M465MX67210 - MynxGrip Vascular Closure Device (6F/7F): 2022-02-15 MynxGrip Vascular Closure Device (6F/7F)
• M465MX67400 - Mynx Ace Vascular Closure Device (6F/7F): 2022-02-15 Mynx Ace Vascular Closure Device (6F/7F)
• 10862028000427 - MYNX CONTROL: 2020-07-21 Mynx Control VCD 5F
• 20862028000400 - MYNXGRIP: 2020-04-17 MynxGrip 5F
• 20862028000417 - MYNXGRIP: 2020-04-17 MynxGrip 6F/7F