FDA.reportPublic FDA data

PILLING

Primary DI
44026704417429
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008075
Catalog number
507956
Device description
MALONEY TUNGSTEN FILLED BOUGIE 56F
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FATBougie, esophageal, and gastrointestinal, gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
44026704417429PackageGS110In Commercial Distribution
24026704417425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670441742944026704417429
2402670441742524026704417425

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461EGCT400EndolumikEndolumik, Inc.FAT2023-05-15
24026704719536PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719543PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719550PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719567PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719574PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719581PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719598PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719604PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719611PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719628PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719635PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719642PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719659PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719666PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719673PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719680PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719697PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719703PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719710PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719727PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719734PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719741PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719758PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719765PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719772PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719789PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719796PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719802PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719819PILLINGTELEFLEX INCORPORATEDFAT2021-03-11