Adstation Oto+
Diagnostix™ - 56802B-56XEU
Device Description
An electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).
Environmental Conditions
- 95.00
- 10.00
- 131.00
- 14.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: IBJ
Device Name: Light, Microscope
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.3600
Third Party Flag: N
Medical Specialty: PA
Code: HLJ
Device Name: Ophthalmoscope, Battery-Powered
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OP
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 886.1570
Third Party Flag: N
Medical Specialty: OP
Code: ERA
Device Name: Otoscope
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 874.4770
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 00634782089207
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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