FDA.reportPublic FDA data

PILLING

Primary DI
24026704526745
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN006874
Catalog number
431120
Published
2018-09-15
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
JYKHOLDER, EAR SPECULUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYKHolder, Ear SpeculumGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704526741Direct MarkingGS10
24026704526745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704526741040267045267414026704526741
2402670452674524026704526745

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Millimeter

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275761Intrace USAPILOTIS TECH LLCJYK2026-07-03
04250676730015MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730022MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730039MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730046MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676734884MENTIO disposable cerumen hookSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676746634MENTIO disposable ear curette/cottonSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
00840183527402BR Surgical, LLCBR Surgical, LLCJYK2024-11-26
G043606200BEARBear-Ent, LLCJYK2023-03-06
G043606220BEARBear-Ent, LLCJYK2023-03-06
G043606230BEARBear-Ent, LLCJYK2023-03-06
G043606280BEARBear-Ent, LLCJYK2022-06-01
B351GC03800mytaMedMytamed, Inc.JYK2021-02-11
B351BGC03800BEARMytamed, Inc.JYK2021-01-18
B351BMN1699V0BEARMytamed, Inc.JYK2021-01-18
04046826110222MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
04046826101787MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
10381780084648Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYK2018-10-24
00821925011663Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
00821925011670GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011687GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011694Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
10381780110866MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110873MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110897MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110910MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110835MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12