FDA.reportPublic FDA data

Latex-free Biliary Catherter

Primary DI
00607915117344
Brand
Latex-free Biliary Catherter
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
CB052308
Device description
Removal of stones and ductal debris from the biliary system.
Published
2015-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607915117344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607915117344006079151173446079151173440607915117344

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length23Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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00607915110147Epix Laparoscopic GrasperC41302016-08-30
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00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729793328MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793335MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
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08714729793397MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793403MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793410MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793427MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793434MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
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08714729793526MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793533MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729029618vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030638Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030645Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030652Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729079552Flexima™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113829vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113836vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113843vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24