Mynx Ace Vascular Closure Device (6F/7F)

Primary DI
M465MX67400
Brand
Mynx Ace Vascular Closure Device (6F/7F)
Company
Access Closure, Inc.
Model
MX6740
Catalog number
MX6740
Device description
Mynx Ace Vascular Closure Device (6F/7F)
Published
2017-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGBDevice, Hemostasis, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGBDevice, Hemostasis, VascularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040044047

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040044047MATRIX VASCULAR CLOSURE SYSTEM (VSG)Cordis US Corporation2005-08-17MGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M465MX67401PackageHIBCC10In Commercial Distribution
M465MX67400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-700-6969customerservice@accessclosure.com
+1(877)700-6969customerservice@accessclosure.com

Regulatory Flags#

DUNS number
132286761
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M465MX50210MynxGrip Vascular Closure Device (5F)MX5021MX50212017-02-06
M465MX67210MynxGrip Vascular Closure Device (6F/7F)MX6721MX67212017-02-06
M465ACX10106Paxwire Occlusion Balloon System ACX101ACX1012016-05-09
20862028000400MYNXGRIPMX5021MX50212017-08-23
20862028000417MYNXGRIPMX6721MX67212017-08-23

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Primary DI, Brand, Company table
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10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
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05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
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10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
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