FDA.report

Reddick Scoop Tip Cholangiogram Catheter

Primary DI
00840663101795
Brand
Reddick Scoop Tip Cholangiogram Catheter
Company
LEMAITRE VASCULAR, INC.
Model
e2401-50
Catalog number
e2401-50
Device description
Reddick Scoop Tip Cholangiogram Catheter, 4F, eIFU
Published
2015-06-30
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
GBZCatheter, Cholangiography

Product Code Classifications

CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840663101795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663101795008406631017958406631017950840663101795

GMDN Terms

TermDefinition
Cholangiopancreatography catheter, single-useA flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP); this is a diagnostic-therapeutic procedure that involves the x-ray of the ducts after introduction of a contrast material. It is typically a single lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
781-221-2266xx@xx.xx

Regulatory Flags

DUNS number
184805166
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
Sterilization required before use
false

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