MynxGrip Vascular Closure Device (5F)

Primary DI
M465MX50210
Brand
MynxGrip Vascular Closure Device (5F)
Company
Access Closure, Inc.
Model
MX5021
Catalog number
MX5021
Device description
MynxGrip Vascular Closure Device (5F)
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
P040044043

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040044043MATRIX VASCULAR CLOSURE SYSTEM (VSG)Cordis US Corporation2005-08-17MGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M465MX50211PackageHIBCC10In Commercial Distribution
M465MX50210PrimaryHIBCC0

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 Gauge5French

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
M465MX67400Mynx Ace Vascular Closure Device (6F/7F)MX6740MX67402017-02-06
M465MX67210MynxGrip Vascular Closure Device (6F/7F)MX6721MX67212017-02-06
M465ACX10106Paxwire Occlusion Balloon System ACX101ACX1012016-05-09
20862028000400MYNXGRIPMX5021MX50212017-08-23
20862028000417MYNXGRIPMX6721MX67212017-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841156111359MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111373MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156103439D-STATTELEFLEX INCORPORATEDMGB2025-07-16
20841156103436D-STATTELEFLEX INCORPORATEDMGB2025-07-16
05391530280617Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FVASORUM LIMITEDMGB2025-04-24
10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109929MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109936MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109950MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109902MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109926MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109933MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109957MANTATELEFLEX INCORPORATEDMGB2024-09-09
10705032090278MYNX CONTROLâ„¢ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
20705032090275MYNX CONTROLâ„¢ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
10841156109080D-STATTELEFLEX INCORPORATEDMGB2023-12-11
20841156109087D-STATTELEFLEX INCORPORATEDMGB2023-12-11
00856279007307MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007321MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007345MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007369MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23