FDA.reportPublic FDA data

PILLING

Primary DI
14026704920065
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN007947
Catalog number
507027
Published
2024-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
54026704920063Direct MarkingGS10
14026704920065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670492006354026704920063
1402670492006514026704920065

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
Length417Millimeter

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
54026704920018PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920025PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920032PILLINGTELEFLEX INCORPORATEDKTR2024-07-15