FDA.reportPublic FDA data

NumenFR

Primary DI
06958698011690
Brand
NumenFR
Company
MicroPort NeuroTech (Shanghai) Co., Ltd.
Model
E101
Device description
The MicroPort NeuroTech NumenFR Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen Coil Embolization System. The device is operated by two pre-loaded batteries.
Published
2022-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
06958698011690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958698011690069586980116906958698011690

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, single-use, sterileA sterile, noninvasive, hand-held, battery-powered unit intended to deliver a low-level electric current to break the connection between a vascular (neurovascular or peripheral) implantable device, and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the desired electrically unstable detachment point. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488178Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28