FDA.reportPublic FDA data

PILLING

Primary DI
04026704399949
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN008058
Catalog number
507922
Device description
MALONEY TUNGSTEN FILLED BOUGIE 22F
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
KTRTUBE, ASPIRATING, BRONCHOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2
KTRTube, Aspirating, Bronchoscope, RigidEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704399949Direct MarkingGS10
44026704417252PackageGS120In Commercial Distribution
24026704399943PrimaryGS10
24026704417258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704399949040267043999494026704399949
4402670441725244026704417252
2402670439994324026704399943
2402670441725824026704417258

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
Length498Millimeter

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
14026704919984PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704919991PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920003PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920010PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920027PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920034PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920058PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920065PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920072PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920096PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920102PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920119PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920133PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920140PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920157PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920164PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920171PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920188PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920195PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920201PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920218PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920225PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920232PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920256PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
14026704920515PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704919982PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704919999PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920001PILLINGTELEFLEX INCORPORATEDKTR2024-07-15