FDA.reportPublic FDA data

PILLING

Primary DI
24026704531824
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN007906
Catalog number
506800
Device description
FEDER-OSSOFF PHONO INST SET
Published
2016-09-16
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
EQNLARYNGOSCOPE, NASOPHARYNGOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQNLaryngoscope, NasopharyngoscopeEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770085000ROBBETT MICROSURGICAL LARYNGOSCOPEEdward Weck, Inc.1977-01-21EQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704531820Direct MarkingGS10
24026704531824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704531820040267045318204026704531820
2402670453182424026704531824

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.75Inch
Width15.25Inch

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
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704927910PILLINGTELEFLEX INCORPORATEDEQN2026-07-08
B366FE1024RX1Nasopharyngoscope, FlexibleEclerisEQN2025-04-16
04580137733195MACHIDAMACHIDA ENDOSCOPE CO.,LTD.EQN2025-04-01
M6334281420JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-05-09
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M63349X40740JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
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M63370702010JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08
M63370702020JEDMEDJEDMED INSTRUMENT COMPANYEQN2023-02-08