FDA.report

Pilling

Primary DI
04026704531301
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN008020
Catalog number
507602
Device description
HURST TUNGSTEN FILLED BOUGIE 34FR
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FATBougie, esophageal, and gastrointestinal, gastro-urology
KAEFORCEPS, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704531301Direct MarkingGS10
44026704417108PackageGS120In Commercial Distribution
24026704417104PrimaryGS10
24026704531305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704531301040267045313014026704531301
4402670441710844026704417108
2402670441710424026704417104
2402670453130524026704531305

GMDN Terms

TermDefinition
Oesophageal bougie, reusableA cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device.

Device Sizes

TypeValueUnit
Length50Centimeter
Length75Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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