FDA.reportPublic FDA data

N/A

Primary DI
06948806353163
Brand
N/A
Company
Synaptic Medical, Ltd.
Model
S0806332LM
Device description
Intracardiac Catheter Introducer Kit
Published
2018-05-17
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

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
06948806353163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948806353163069488063531636948806353163

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421256891
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
06948806353170N/AS0806332LM12018-05-17
06948806353187N/AS0856238RM22018-05-17
06948806353194N/AS0856332LM2S0856332LM22018-07-30
06948806354016NAN18710AN18710A2016-11-15

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Primary DI, Brand, Company table
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10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
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10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27