FDA.reportPublic FDA data

LABTRON

Primary DI
M368122711
Brand
LABTRON
Company
GF HEALTH PRODUCTS, INC.
Model
1227-1
Device description
Otoscope Set
Published
2020-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M368122712PackageHIBCC20In Commercial Distribution
M368122711PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

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
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
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