FDA.report

Syntel® Biliary Catheters

Primary DI
00607915111007
Brand
Syntel® Biliary Catheters
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
A4762
Device description
Used for the removal of stones and ductal debris from the biliary system.
Published
2015-06-19
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

Related Records

Contact Domains

Product Codes

CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00607915111007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00607915111007006079151110076079151110070607915111007

GMDN Terms

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

TypeValueUnit
Catheter Gauge6French
Length23Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags

DUNS number
187129135
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
true
Sterilization required before use
false

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