FDA.reportPublic FDA data

NA

Primary DI
06948806354115
Brand
NA
Company
Synaptic Medical, Ltd.
Model
N18980A
Catalog number
N18980A
Device description
Transseptal Needle
Published
2016-11-15
Public version status
Update
Distribution status
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
DRCTrocar
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948806354115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948806354115069488063541156948806354115

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Length980Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+861051297209service@synapticmed.com.cn

Regulatory Flags#

DUNS number
421256891
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948806322107NAS08574LVS08574LV2024-12-06
06948806353019NAS0806238R0S0806238R02016-11-15
06948806353026NAS0806332L1S0806332L12016-11-15
06948806353033NAS0808138R0S0808138R02016-11-15
06948806353040NAS0808132L1S0808132L12016-11-15
06948806353057NAS0856238R0S0856238R02016-11-15
06948806353064NAS0856332L1S0856332L12016-11-15
06948806353071NAS0858132L1S0858132L12016-11-15
06948806353088NAS0858138R0S0858138R02016-11-15
06948806353095N/AS0806332L22018-05-17
06948806353101N/AS0808132L22018-05-17
06948806353118N/AS0856332L22018-05-17
06948806353125N/AS0856332LM2018-05-17
06948806353132N/AS0856238RM1 2018-05-17
06948806353149N/AS0856332L02018-05-17
06948806353156N/AS0806332L02018-05-17
06948806353163N/AS0806332LM2018-05-17
06948806353170N/AS0806332LM12018-05-17
06948806353187N/AS0856238RM22018-05-17
06948806353194N/AS0856332LM2S0856332LM22018-07-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
07613252722915NASTRYKER CORPORATIONDYB2016-09-23
07613327115888NASTRYKER CORPORATIONDYB2016-09-23
07613327115901NASTRYKER CORPORATIONDYB2016-09-23
07613327115918NASTRYKER CORPORATIONDYB2016-09-23
07613327115925NASTRYKER CORPORATIONDYB2016-09-23
07613327115949NASTRYKER CORPORATIONDYB2016-09-23
07613327115956NASTRYKER CORPORATIONDYB2016-09-23
07613327115963NASTRYKER CORPORATIONDYB2016-09-23