FDA.reportPublic FDA data

DuraSheath Introducer Sheath System

Primary DI
04251244500153
Brand
DuraSheath Introducer Sheath System
Company
Contract Medical International GmbH
Model
5F, 90cm, straigth
Catalog number
FG-05090
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Published
2019-06-30
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
14251244500150PackageGS15Not in Commercial Distribution
24251244500157PackageGS11Not in Commercial Distribution
04251244500153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450015014251244500150
2425124450015724251244500157
04251244500153042512445001534251244500153

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
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
04251244500719DuraSheath Introducer Sheath System6F, 15cm, straight, firmFG-06015-F2021-04-20
04251244500795DuraSheath Introducer Sheath System7F, 45cm, straigth, firmFG-07045-F2020-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500177DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30