FDA.reportPublic FDA data

Numen

Primary DI
06958698010389
Brand
Numen
Company
MicroPort NeuroTech (Shanghai) Co., Ltd.
Model
3D2058FR
Device description
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use.The Numen Coil Embolization System is composed of two parts as described below:*An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter.*The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
Published
2022-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203625000
K232955000
K242154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203625000Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2021-09-01HCG
K232955000Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10HCG
K242154000Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958698010389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958698010389069586980103896958698010389

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551973856
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06958698025260Numen3D0102FNM22024-11-06
06958698025277Numen3D0103FNM22024-11-06
06958698025284Numen3D1H02FNM22024-11-06
06958698025291Numen3D1H03FNM22024-11-06
06958698025307Numen3D1H04FNM22024-11-06
06958698025314Numen3D0202FNM22024-11-06
06958698025321Numen3D0203FNM22024-11-06
06958698025338Numen3D0204FNM22024-11-06
06958698025345Numen3D0206FNM22024-11-06
06958698025352Numen3D0208FNM22024-11-06
06958698025369Numen3D2H03FNM22024-11-06
06958698025376Numen3D2H04FNM22024-11-06
06958698025383Numen3D2H06FNM22024-11-06
06958698025390Numen3D2H08FNM22024-11-06
06958698025406Numen3D0304FNM22024-11-06
06958698025413Numen3D0306FNM22024-11-06
06958698025420Numen3D0308FNM22024-11-06
06958698025437Numen3D0310FNM22024-11-06
06958698025444Numen3D0315FNM22024-11-06
06958698025451Numen3D3H06FNM22024-11-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327578614Target TetraStryker CorporationHCG2022-12-19
07613327578621Target TetraStryker CorporationHCG2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578645Target TetraStryker CorporationHCG2022-12-19
07613327578652Target TetraStryker CorporationHCG2022-12-19
07613327578669Target TetraStryker CorporationHCG2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
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07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578713Target TetraStryker CorporationHCG2022-12-19
07613327578720Target TetraStryker CorporationHCG2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
07613327580105Target TetraStryker CorporationHCG2022-12-19
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07613327466386TARGETStryker CorporationKRD2019-09-05
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07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
07613327128307TARGETStryker CorporationHCG2017-06-26
07613327128345TARGETStryker CorporationHCG2017-06-26
07613327128352TARGETStryker CorporationKRD2017-06-26
07613327128369TARGETStryker CorporationKRD2017-06-26