FDA.reportPublic FDA data

Lotus™ Introducer Set

Primary DI
05391526210116
Brand
Lotus™ Introducer Set
Company
CREGANNA UNLIMITED COMPANY
Model
H749NTR200
Catalog number
LIS-L
Device description
Lotus™ Introducer Set, Large
Published
2016-09-23
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
05391526210116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391526210116053915262101165391526210116

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length30.5Centimeter
Length47.5Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985218606
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391526210031Zurpaz™ Steerable Sheath SetM004EPTMC85300M004EPTMC853002016-09-23
05391526210048Zurpaz™ Steerable Sheath SetM004EPTMCA85400M004EPTMCA854002016-09-23
05391526210055Zurpaz™ Steerable Sheath SetM004USMC85100M004USMC851002016-09-23
05391526210062Zurpaz™ Steerable Sheath SetM004USMCA85200M004USMCA852002016-09-23
05391526210079Zurpaz™ Steerable Sheath SetM004JPNMC85500M004JPNMC855002016-09-23
05391526210086Zurpaz™ Steerable Sheath SetM004JPNMCA85600M004JPNMCA856002016-09-23
05391526210253Attain Assist™ CS Access Catheter146168-01146168-012019-01-14
05391526210017Gore TIPS® SheathTSTH1040TSTH10402016-09-23
05391526210109Lotus™ Introducer SetH749NTR180LIS-S2016-09-23
25391526210028Gore TIPS SetTSET1016TSET10162016-09-23
05391526210000Gore TIPS NeedleTNDL1656TNDL16562016-09-23
05391526210154Trapper™ Exchange DeviceH74939330130H749393301302017-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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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
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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