FDA.report

PILLING

Primary DI
04026704531899
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008035
Catalog number
507808
Device description
JACKSON ESOPHAGEAL DILATOR 8 FR
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
KCFDILATOR, ESOPHAGEAL, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KCFDilator, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704531899Direct MarkingGS10
24026704532388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704531899040267045318994026704531899
2402670453238824026704532388

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
Length25Inch

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

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