FDA.reportPublic FDA data

PILLING

Primary DI
54026704920001
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN007941
Catalog number
507012
Device description
ASPIRATING TUBE OPEN END 40CM
Published
2024-07-15
Public version status
New
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
KTRTube, aspirating, bronchoscope, rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTRTube, Aspirating, Bronchoscope, RigidEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704920001Direct MarkingGS10
14026704920003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670492000154026704920001
1402670492000314026704920003

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length447Millimeter

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
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

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
54026704919982PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704919999PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920018PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920025PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920032PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920056PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920063PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920070PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920094PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920100PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920117PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920131PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920148PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920155PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920162PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920179PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920186PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920193PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920209PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920216PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920223PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704921992PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920254PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920513PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
24026704537222PILLINGTELEFLEX INCORPORATEDKTR2016-09-16
04026704530878PILLINGTELEFLEX INCORPORATEDKTR2016-09-16
04026704530885PILLINGTELEFLEX INCORPORATEDKTR2016-09-16
04026704530908PILLINGTELEFLEX INCORPORATEDKTR2016-09-16
04026704530915PILLINGTELEFLEX INCORPORATEDKTR2016-09-16
04026704530922PILLINGTELEFLEX INCORPORATEDKTR2016-09-16