Penguin ENT Scope model

Primary DI
04711099370016
Brand
Penguin ENT Scope model
Company
OPCOM INC.
Model
CP1310F6
Device description
Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses:Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion.Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems.Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene.Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04711099370016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711099370016047110993700164711099370016

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657204525
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04711099370009Meerkat Vein Finder modelCM3100FF62024-12-20
04711099370023Duck Intraoral camera modelCD1310F62024-12-20
04711099370047Penguin ENT Scope model CP1313F62024-12-20
04711099370054Duck Intraoral camera modelCD1313F62024-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
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
10304040029203Henry ScheinHENRY SCHEIN, INC.ERA2018-12-21
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