FDA.reportPublic FDA data

DuraSheath Introducer Sheath System

Primary DI
24251244500171
Brand
DuraSheath Introducer Sheath System
Company
Contract Medical International GmbH
Model
6F, 60cm, straigth
Catalog number
FG-06060
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Published
2019-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14251244500174PackageGS15In Commercial Distribution
24251244500171PackageGS11In Commercial Distribution
04251244500177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450017414251244500174
2425124450017124251244500171
04251244500177042512445001774251244500177

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
Length60Centimeter
Lumen/Inner Diameter2.25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493512138888regulatory@contract-medical.com
+493512138888hmdd.regulatory@heraeus.com

Regulatory Flags#

DUNS number
330926895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251244502768Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
04251244502775Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
04251244502782Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
14251244502765Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
14251244502772Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
14251244502789Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
04251244503604Biotronik Fortress Introducer Sheath System4F; 45 cm; straight3588142024-06-24
04251244503611Biotronik Fortress Introducer Sheath System4F; 100 cm; straight358815 2024-06-24
04251244503628Biotronik Fortress Introducer Sheath System4F; 45 cm; crossover358813 2024-06-24
04251244503635Biotronik Fortress Introducer Sheath System4F; 65 cm; straight444486 2024-06-24
04251244503642Biotronik Fortress Introducer Sheath System4F; 90 cm; straight4444852024-06-24
04251244503659Biotronik Fortress Introducer Sheath System5F; 45 cm; straight386591 2024-06-24
04251244503666Biotronik Fortress Introducer Sheath System5F; 100 cm; straight386592 2024-06-24
04251244503673Biotronik Fortress Introducer Sheath System5F; 45 cm; crossover3865902024-06-24
04251244503680Biotronik Fortress Introducer Sheath System5F; 65 cm; straight444484 2024-06-24
04251244503697Biotronik Fortress Introducer Sheath System5F; 90 cm; straight444483 2024-06-24
04251244503703Biotronik Fortress Introducer Sheath System6F; 45 cm; straight386594 2024-06-24
04251244503710Biotronik Fortress Introducer Sheath System6F; 100 cm; straight386595 2024-06-24
04251244503727Biotronik Fortress Introducer Sheath System6F; 45 cm; crossover386593 2024-06-24
04251244503734Biotronik Fortress Introducer Sheath System6F; 65 cm; straight444482 2024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355120ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355130ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355160ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355170ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355180ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355190ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965481000ENVINAVILYST MEDICAL, INC.DYB2017-08-07