FDA.reportPublic FDA data

NA

Primary DI
06948806354016
Brand
NA
Company
Synaptic Medical, Ltd.
Model
N18710A
Catalog number
N18710A
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948806354016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948806354016069488063540166948806354016

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length710Millimeter
Needle Gauge18Gauge

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135391Redemption VILEX LLCDRC2026-01-12
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28
00858769006241Transseptal NeedlePPMDMDRC2018-11-28
00858769006258Transseptal NeedlePPMDMDRC2018-11-28
10884450151850Merit Advance®Merit Medical Systems, Inc.DRC2018-06-11
00858769006104SafeSept Transseptal GuidwirePPMDMDRC2018-03-02