FDA.report

PILLING

Primary DI
04026704531387
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008024
Catalog number
507606
Device description
HURST TUNGSTEN FILLED BOUGIE 42FR
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
EOQBronchoscope (flexible or rigid)
FATBougie, esophageal, and gastrointestinal, gastro-urology

Product Code Classifications

CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704531387Direct MarkingGS10
44026704417146PackageGS120In Commercial Distribution
24026704417142PrimaryGS10
24026704531381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704531387040267045313874026704531387
4402670441714644026704417146
2402670441714224026704417142
2402670453138124026704531381

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
Length45Centimeter
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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