ENT Pocket Light

Primary DI
00850013958016
Brand
ENT Pocket Light
Company
C F M TECHNOLOGIES INC
Model
PL2 Blue
Catalog number
ENT-PL2-BL
Device description
ENT Pocket Light - Basic Set Otoscope set with disposable specula and nasal head.
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013958016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013958016008500139580168500139580160850013958016

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
00850013958023ENT POCKET LIGHTPL3 BLACKPL3-BK2020-01-03
00850013958030ENT POCKET LIGHTPL3 BLUEPL3-BL2020-01-03
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

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Primary DI, Brand, Company table
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KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
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20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
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17290018446154Nonagon N9+NONAGON LTDERA2022-09-28
27290018446151Nonagon N9+ SmartExamNONAGON LTDERA2022-09-28
M368122711LABTRONGF HEALTH PRODUCTS, INC.ERA2020-09-15
H65811255271Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
H65811255281Henry ScheinHENRY SCHEIN, INC.ERA2020-06-16
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10304040029197Henry ScheinHENRY SCHEIN, INC.ERA2018-09-24
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