FDA.report

Proscope™

Primary DI
00634782853228
Brand
Proscope™
Company
AMERICAN DIAGNOSTIC CORP
Model
5312
Catalog number
5312
Device description
PROSCOPE Dermascope,
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IBJLight, Microscope

Product Code Classifications

CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782853228PackageGS16In Commercial Distribution
00634782053437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782853228006347828532286347828532280634782853228
00634782053437006347820534376347820534370634782053437

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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