FDA.reportPublic FDA data

Catapult Guide Sheath

Primary DI
04251244501976
Brand
Catapult Guide Sheath
Company
Contract Medical International GmbH
Model
4F, 15cm, straight, hydrophilic coated
Catalog number
US-34015-F-ST-H
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. Introducer Sheath is hydrophilic coated on the distal end.
Published
2023-09-01
Public version status
Update
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
DREDilator, Vessel, For Percutaneous Catheterization
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251244501973PackageGS15In Commercial Distribution
24251244501970PackageGS11In Commercial Distribution
04251244501976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450197314251244501973
2425124450197024251244501970
04251244501976042512445019764251244501976

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
Catheter Inner Diameter0
Length0

Storage And Handling#

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

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251244501983Catapult Guide Sheath4F, 45cm, straight, hydrophilic coatedUS-34045-F-ST-H2023-09-01
04251244501990Catapult Guide Sheath4F, 60cm, straight, hydrophilic coatedUS-34060-F-ST-H2023-09-01
04251244502003Catapult Guide Sheath4F, 90cm, straight, hydrophilic coatedUS-34090-F-ST-H2023-09-01
04251244502010Catapult Guide Sheath5F, 15cm, straight, hydrophilic coatedUS-35015-F-ST-H2023-09-01
04251244502027Catapult Guide Sheath5F, 45cm, straight, hydrophilic coatedUS-35045-F-ST-H2023-09-01
04251244502034Catapult Guide Sheath5F, 45cm, Multipurpose, hydrophilic coatedUS-35045-F-MP-H2023-09-01
04251244502041Catapult Guide Sheath5F, 45cm, RDC, hydrophilic coatedUS-35045-F-RDC-H2023-09-01
04251244502058Catapult Guide Sheath5F, 45cm, Hockey stick, hydrophilic coatedUS-35045-F-HS-H2023-09-01
04251244502065Catapult Guide Sheath5F, 60cm, straight, hydrophilic coatedUS-35060-F-ST-H2023-09-01
04251244502072Catapult Guide Sheath5F, 90cm, straight, hydrophilic coatedUS-35090-F-ST-H2023-09-01
04251244502089Catapult Guide Sheath6F, 15cm, straight, hydrophilic coatedUS-36015-F-ST-H2023-09-01
04251244502096Catapult Guide Sheath6F, 45cm, straight, hydrophilic coatedUS-36045-F-ST-H2023-09-01
04251244502102Catapult Guide Sheath6F, 45cm, Multipurpose, hydrophilic coatedUS-36045-F-MP-H2023-09-01
04251244502119Catapult Guide Sheath6F, 45cm, LIMA, hydrophilic coatedUS-36045-F-LIMA-H2023-09-01
04251244502126Catapult Guide Sheath6F, 45cm, RDC, hydrophilic coatedUS-36045-F-RDC-H2023-09-01
04251244502133Catapult Guide Sheath6F, 45cm, Hockey stick, hydrophilic coatedUS-36045-F-HS-H2023-09-01
04251244502140Catapult Guide Sheath6F, 60cm, straight, hydrophilic coatedUS-36060-F-ST-H2023-09-01
04251244502157Catapult Guide Sheath6F, 90cm, straight, hydrophilic coatedUS-36090-F-ST-H2023-09-01
04251244502164Catapult Guide Sheath6F, 90cm, Multipurpose, hydrophilic coatedUS-36090-F-MP-H2023-09-01
04251244502171Catapult Guide Sheath6F, 90cm, RDC, hydrophilic coatedUS-36090-F-RDC-H2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
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10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
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10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23