FDA.reportPublic FDA data

PILLING

Primary DI
04026704530922
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN007943
Catalog number
507014
Device description
ASPIRATING TUBE OPEN END 50CM
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
JEKFORCEPS, BIOPSY, BRONCHOSCOPE (RIGID)
KTRTUBE, ASPIRATING, BRONCHOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEKForceps, Biopsy, Bronchoscope (Rigid)Ear, Nose, Throat2
KTRTube, Aspirating, Bronchoscope, RigidEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990561000OPTICAL FORCEPSPilling Weck Surgical1999-05-14JEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704530922Direct MarkingGS10
24026704399851PrimaryGS10
24026704530926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704530922040267045309224026704530922
2402670439985124026704399851
2402670453092624026704530926

GMDN Terms#

Term, Definition table
TermDefinition
Bronchoscopic aspiration tube, rigidA rigid, endotherapy device used in combination with a compatible bronchoscope and intended to be used for aspiration of, e.g., body waste from the respiratory tract and the bronchi of the lungs during bronchoscopy. It is typically made of a metal or plastic tube. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28.2Centimeter
Length548Millimeter

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
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
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09
10801902228083ARROWAK-05560AK-055602026-10-09
10801902228090ARROWAK-05502AK-055022026-10-09

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
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
54026704920018PILLINGTELEFLEX INCORPORATEDKTR2024-07-15
54026704920025PILLINGTELEFLEX INCORPORATEDKTR2024-07-15