FDA.reportPublic FDA data

Safety Excalibur Introducer System with Punctur-Guard

Primary DI
10801741074810
Brand
Safety Excalibur Introducer System with Punctur-Guard
Company
Bard Access Systems, Inc.
Model
4035413
Catalog number
4035413
Device description
EXCALIBUR INTRO 5FR
Published
2017-02-06
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741074810PackageGS15In Commercial Distribution
00801741074813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107481010801741074810
00801741074813008017410748138017410748130801741074813

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length37Millimeter
Needle Gauge15Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007541VYGONVygon CorporationDYB2026-05-22
00849884007558VYGONVygon CorporationDYB2026-05-22
20886333227864V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.DYB2026-03-11
20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
20884450113992Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
20884450115804Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.DYB2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
20801902225362ARROWTELEFLEX INCORPORATEDDYB2026-02-17
20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13