FDA.reportPublic FDA data

DuraSheath Introducer Sheath System

Primary DI
04251244500719
Brand
DuraSheath Introducer Sheath System
Company
Contract Medical International GmbH
Model
6F, 15cm, straight, firm
Catalog number
FG-06015-F
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Published
2021-04-20
Public version status
Update
Distribution status
Not 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
14251244500716PackageGS15Not in Commercial Distribution
24251244500713PackageGS11Not in Commercial Distribution
04251244500719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450071614251244500716
2425124450071324251244500713
04251244500719042512445007194251244500719

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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
Length0
Lumen/Inner Diameter0

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+493512138888medevioregulatoryaffairs@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
04251244500108DuraSheath Introducer Sheath System4F, 45cm, straigthFG-040452019-06-30
04251244500115DuraSheath Introducer Sheath System4F, 60cm, straigthFG-040602019-06-30
04251244500122DuraSheath Introducer Sheath System4F, 90cm, straigthFG-040902019-06-30
04251244500139DuraSheath Introducer Sheath System5F, 45cm, straigthFG-050452019-06-30
04251244500146DuraSheath Introducer Sheath System5F, 60cm, straigthFG-050602019-06-30
04251244500153DuraSheath Introducer Sheath System5F, 90cm, straigthFG-050902019-06-30
04251244500177DuraSheath Introducer Sheath System6F, 60cm, straigthFG-060602019-06-30
04251244500184DuraSheath Introducer Sheath System6F, 90cm, straigthFG-060902019-06-30
04251244500306DuraSheath Introducer Sheath System7F, 90cm, straigthFG-070902019-06-30
04251244500313DuraSheath Introducer Sheath System8F, 90cm, straigthFG-080902019-06-30
04251244500443DuraSheath Introducer Sheath System7F, 45cm, straigthFG-070452019-06-30
04251244500450DuraSheath Introducer Sheath System7F, 60cm, straigthFG-070602019-06-30
04251244500467DuraSheath Introducer Sheath System8F, 45cm, straigthFG-080452019-06-30
04251244500474DuraSheath Introducer Sheath System8F, 60cm, straigthFG-080602019-06-30
04251244500481DuraSheath Introducer Sheath System4F, 15cm, straigthFG-040152019-06-30
04251244500610DuraSheath Introducer Sheath System5F, 15cm, straigthFG-050152019-06-30
04251244500627DuraSheath Introducer Sheath System6F, 15cm, straigthFG-060152019-06-30
04251244500641DuraSheath Introducer Sheath System6F, 60cm, straight, firmFG-06060-F2021-04-20
04251244500658DuraSheath Introducer Sheath System6F, 90cm, straigth, firmFG-06090-F2019-02-12
04251244500795DuraSheath Introducer Sheath System7F, 45cm, straigth, firmFG-07045-F2020-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628308GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628322GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628346GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628094GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-01-09