FDA.reportPublic FDA data

NA

Primary DI
06948806353033
Brand
NA
Company
Synaptic Medical, Ltd.
Model
S0808138R0
Catalog number
S0808138R0
Device description
Intracardiac Catheter Introducer Kit
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948806353033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948806353033069488063530336948806353033

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
Catheter Gauge8French

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
421256891
Device count
1
Kit
true
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
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
06948806354016NAN18710AN18710A2016-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
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
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
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