FDA.reportPublic FDA data

PILLING

Primary DI
44026704417290
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008062
Catalog number
507930
Device description
MALONEY TUNGSTEN FILLED BOUGIE 30F
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
04026704417292Direct MarkingGS10
44026704417290PackageGS130In Commercial Distribution
24026704417296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704417292040267044172924026704417292
4402670441729044026704417290
2402670441729624026704417296

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Centimeter

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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461EGCT36M0EndolumikEndolumik, Inc.FAT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.FAT2024-08-06
G461EGCT360EndolumikEndolumik, Inc.FAT2023-05-15
G461EGCT400EndolumikEndolumik, Inc.FAT2023-05-15
14026704719539PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719546PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719553PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719560PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719577PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719584PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719591PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719607PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719614PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719621PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719638PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719645PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719652PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719669PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719676PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719683PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719690PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719706PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719713PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719720PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719737PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719744PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719751PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719768PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719775PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719782PILLINGTELEFLEX INCORPORATEDFAT2021-03-11