FDA.reportPublic FDA data

AED

Primary DI
00848657077330
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
8800AXS
Device description
AED OTOSCOPE 4MM X 0 DEGREE, 50MM
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00848657077330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657077330008486570773308486570773300848657077330

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078535AEDAED2717B2026-10-20
00848657078542AEDAED2718B2026-10-20
00848657078559AEDAED2719B2026-10-20
00848657078481AED8815SB2026-10-08
00848657078498AED8810SB2026-10-08
00848657078504AED1010122026-10-08
00848657078511AED10121-A2026-10-08
00848657078528AEDAED26173AD2026-10-08
00848657083805AED1010162026-10-08
00848657083904AED1010012026-10-08
00848657078467AED101021-A2026-10-05
00848657078474AED101011-A2026-10-05
00848657083782AED1012112026-10-05
00848657083812AED1013112026-10-05
00848657083843AED1010662026-10-05
00848657083874AED1010002026-10-05
00848657083898AED1010212026-10-05
00848657084956AED101013T2026-10-05
00848657084963AED101066-L2026-10-05
00848657084970AED101066-S2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102456Diagnostix™AMERICAN DIAGNOSTIC CORPERA2026-10-06
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