FDA.reportPublic FDA data

ENT POCKET LIGHT

Primary DI
00850013958047
Brand
ENT POCKET LIGHT
Company
C F M TECHNOLOGIES INC
Model
PL4 BLACK
Catalog number
PL4-BK
Device description
Deluxe ENT Pocket Light Set Otoscope set with reusable and single ear curettes and nasal head. Black
Published
2020-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope
JYGCurette, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013958047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013958047008500139580478500139580470850013958047

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, single-useA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and for procedures during middle ear surgery (e.g., removal of the superior bony rim). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6039243751cfm@cfmtechnologies.com

Regulatory Flags#

DUNS number
040748944
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013958009ENT Pocket LightPL2 BlackENT-PL2-BK2019-11-25
00850013958139CFM TechnologiesENT-BFKENT-BFK2020-01-06
00850013958146CFM TechnologiesENT-DFKENT-DFK2020-01-06
00850013958245CFM TechnologiesENT-BMK2020-01-06
00850013958252CFM TechnologiesENT-DMK2020-01-06
00850013958016ENT Pocket LightPL2 BlueENT-PL2-BL2020-01-03
00850013958023ENT POCKET LIGHTPL3 BLACKPL3-BK2020-01-03
00850013958030ENT POCKET LIGHTPL3 BLUEPL3-BL2020-01-03
00850013958054ENT POCKET LIGHTPL4 BLUEPL4-BL2020-01-03
00850013958061CFM TechnologiesCM1 BlackCM1-BK2020-01-06
00850013958078CFM TechnologiesCM1 BlueCM1-BL2020-01-06
00850013958085CFM TechnologiesCM2 blackCM2-BK2020-01-06
00850013958092CFM TechnologiesCM2 BlueCM2-BL2020-01-06
00850013958108CFM TEechnologiesCM3 BLACKCM3-BK2020-01-06
00850013958115CFM TechnologiesCM3 BlueCM3-BL2020-01-06
00850013958122Wizard WandWW-012020-01-06
00850013958153CFM TechnologiesENT-LS2020-01-06
00850013958160CFM TechnologiesLS7ENT-LS72020-01-06
00850013958177CFM TechnologiesSU-C4LB-SU-C42020-01-06
00850013958184CFM TechnologiesSU-C3LB-SU-C32020-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811100603INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100825INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100832INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100856INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
20888277660196MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
08904461000321OSSEOUS Rosen InserterEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319620OSSEOUS Jobson Horne Probe-RoundEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319637OSSEOUS Jobson Horne Probe-OvalEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319644OSSEOUS Cerumen hookEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319668OSSEOUS Myringotomy knifeEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
20888277660202MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20193489141495MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141501MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141518MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141525MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141532MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141549MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141556MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141563MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141570MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141587MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141594MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18