FDA.reportPublic FDA data

Proscope™

Primary DI
00634782053550
Brand
Proscope™
Company
AMERICAN DIAGNOSTIC CORP
Model
5215-M4
Catalog number
5215-M4
Device description
Laryngeal Mirror #4,
Published
2016-09-21
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
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782853341PackageGS110In Commercial Distribution
00634782053550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782853341006347828533416347828533410634782853341
00634782053550006347820535506347820535500634782053550

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit120.2 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102159Diagnostix™805NWWA805NWWA2026-08-26
00634782102166Diagnostix™805NMWA805NMWA2026-08-26
00634782102173Diagnostix™805NDWA805NDWA2026-08-26
00634782102197Adcuff™885TAWA885TAWA2026-08-26
00634782102203Adcuff™885NWA885NWA2026-08-26
00634782102210Adcuff™886NWA886NWA2026-08-26
00634782101459Prosphyg™760-11ABCAA760-11ABCAA2026-08-25
00634782101633Diagnostix™2101CN2101CN2026-08-25
00634782101848Adscope®603BKAC603BKAC2026-08-25
00634782102098Proscope™664BKKM664BKKM2026-08-25
00634782102104Proscope™664YKM664YKM2026-08-25
00634782102111Proscope™665YKM665YKM2026-08-25
00634782102128Adsoft™660-08BK660-08BK2026-08-25
00634782102180Diagnostix™805NWA805NWA2026-08-25
00634782102265Advantage™6121KIT6121KIT2026-08-25
00634782045708Proscope™665Y665Y2016-09-21
00634782098384Adscope®603-04W603-04W2026-03-30
00634782099473Prosphyg™760-11ABCAAQ760-11ABCAAQ2023-01-11
00634782102258Adscope®608CFST608CFST2026-06-02
00634782603045ADC54202542022026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462902880evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902910evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902934evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902941evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902958evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902972evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902989evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902996evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903061evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903078evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903085evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902767evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902774evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902781evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902798evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902804evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902811evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902828evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902835evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902842evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902859evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902866evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902873evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902897evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902927evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903009evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903016evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18