FDA.reportPublic FDA data

MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F

Primary DI
10705032090278
Brand
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
Company
Cordis US Corp.
Model
MX61260
Catalog number
MX61260
Device description
MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
P040044097

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040044097MATRIX VASCULAR CLOSURE SYSTEM (VSG)Cordis US Corporation2005-08-17MGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032090275PackageGS110In Commercial Distribution
10705032090278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503209027520705032090275
1070503209027810705032090278

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.

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000086RAIN Sheath® Tibial Pedal IntroducerTP506410NTP506410N2023-05-05
10705032000093RAIN Sheath® Tibial Pedal IntroducerTP506410STP506410S2023-05-05
10705032078894RAIN Sheath Transradial506616H506616H2018-10-09
10705032078924RAIN Sheath Transradial506716H506716H2018-10-09
10705032078931RAIN Sheath Transradial506416S506416S2018-10-09
10705032078948RAIN Sheath Transradial506610S506610S2018-10-09
10705032078955RAIN Sheath Transradial506710S506710S2018-10-09
10705032078962RAIN Sheath Transradial506410H506410H2018-10-09
10705032078979RAIN Sheath Transradial506510H506510H2018-10-09
10705032078986RAIN Sheath Transradial506716S506716S2018-10-09
10705032078993RAIN Sheath Transradial506416H506416H2018-10-09
10705032079006RAIN Sheath Transradial506616S506616S2018-10-09
10705032079013RAIN Sheath Transradial506710H506710H2018-10-09
10705032079037RAIN Sheath Transradial506610H506610H2018-10-09
10705032082068RAIN Sheath Transradial506410P20G506410P20G2020-12-17
10705032082075RAIN Sheath Transradial506716P22G506716P22G2020-12-17
10705032082082RAIN Sheath Transradial506616P22G506616P22G2020-12-17
10705032082105RAIN Sheath Transradial506510P22G506510P22G2020-12-17
10705032082112RAIN Sheath Transradial506510P20G506510P20G2020-12-17
10705032082129RAIN Sheath Transradial506516N506516N2020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
20705032090275MYNX CONTROL™ 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
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00856279007369MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
10856279007304MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23