FDA.reportPublic FDA data

ENT POCKET LIGHT

Primary DI
00850013958030
Brand
ENT POCKET LIGHT
Company
C F M TECHNOLOGIES INC
Model
PL3 BLUE
Catalog number
PL3-BL
Device description
Deluxe ENT Pocket Light Set Otoscope set with reusable ear curettes and nasal head. Blue
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
00850013958030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013958030008500139580308500139580300850013958030

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable 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
00850013958047ENT POCKET LIGHTPL4 BLACKPL4-BK2020-01-03
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
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901647evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901654evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901661evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908141evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422356MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422363MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31
00190776403331MillenniumAvalign Technologies, Inc.JYG2026-07-21
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20