FDA.reportPublic FDA data

ASTODIA

Primary DI
04260114140214
Brand
ASTODIA
Company
Stihler Electronic GmbH
Model
DIA100
Device description
DIA100
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJNTransilluminator, battery-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260114140214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260114140214042601141402144260114140214

GMDN Terms#

Term, Definition table
TermDefinition
Skin transilluminator, battery-poweredA hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317742377
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260114140221ASTOPAD®COV070-NACOV070-NA2020-10-08
04260114140238ASTOPAD®COV105-NACOV105-NA2020-10-08
04260114140245ASTOPAD®COV150-NACOV150-NA2020-10-08
04260114140252ASTOPAD®COV155-NACOV155-NA2020-10-08
04260114140269ASTOPAD®COV180-NACOV180-NA2020-10-08
04260114140030ASTOPAD®DUO310-NADUO310-NA2020-10-07
04260114141433ASTOTUBE®M77455502M774555022024-08-16
04260114141440ASTOTUBE®M774600022024-08-16
04260114141389ASTOTUBE®M77455502M774555022024-08-16
04260114141396ASTOTUBE®M774600022024-08-16
04260114140610ASTOTUBE®IFT40410IFT404102016-09-07
04260114140627ASTOTUBE®IFT30350IFT303502016-09-07
04260114140634ASTOTUBE®IFT30460IFT304602016-09-07
04260114140641ASTOTUBE®IFT30410IFT304102016-08-11
04260114140375ASTOTHERM® PLUSAP220EUAP220EU2016-08-31
04260114140382ASTOTHERM® PLUSAP220SEUAP220SEU2016-08-31
04260114140399ASTOTHERM® PLUSAP260EUAP260EU2016-08-31
04260114140405ASTOTHERM® PLUSAP260SEUAP260SEU2016-08-31
04260114140443ASTOLINEAL222AL2222016-08-31
04260114140450ASTOLINEAL260AL2602016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544050zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544678zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544692zumaxZumax Medical Co., LTDHJN2026-05-21
B945BERAI0BernellBernellHJN2026-05-02
B945MTBIFL0BernellBernellHJN2026-05-02
B945MTBIH20BernellBernellHJN2026-05-02
00697077003166Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
00697077003173Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2025-07-17
00850064466348VF1000LED Vein locatorFABINJECT LLCHJN2025-03-02
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00732094074130Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074185Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074192Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082708Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082715Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082739Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2022-12-21
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
10812594013000NeoGlo DisposableNeotech Products LLCHJN2021-05-20
10812594013062NeoGlo DisposableNeotech Products LLCHJN2021-05-20
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20