FDA.reportPublic FDA data

EPAD

Primary DI
00851641007015
Brand
EPAD
Company
SAFEOP SURGICAL, INC.
Model
EPAD
Catalog number
100032
Device description
EPAD Control Box /Head Box
Published
2016-12-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFStimulator, Electrical, Evoked Response
IKNElectromyograph, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851641007015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851641007015008516410070158516410070150851641007015

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4107739601info@safeopsurgical.com

Regulatory Flags#

DUNS number
078641162
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851641007183EPADEPAD1005072016-12-14
00851641007190EPADEPAD1005082016-12-14
00851641007206EPADEPAD2000112017-06-09
00851641007008EPADEPAD1000852016-12-14
00851641007022EPADEPAD1000592017-06-09
00851641007039EPADEPAD1000862017-06-09
00851641007046EPADEPAD1000872017-06-09
00851641007053EPADEPAD1003892017-06-09
00851641007060EPADEPAD1003902017-06-09
00851641007077EPADEPAD1000242017-06-09
00851641007084EPADEPAD1000232016-12-14
00851641007091EPADEPAD1000222017-05-10
00851641007107EPADEPAD1000212017-06-09
00851641007114EPADEPAD1000282017-06-09
00851641007121EPADEPAD1000272017-06-09
00851641007138EPADEPAD1000262017-06-09
00851641007145EPADEPAD1000252017-05-10
00851641007152EPADEPAD1005132017-06-09
00851641007169EPADEPAD1005122017-06-09
00851641007176EPADEPAD2000102017-06-09

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Primary DI, Brand, Company table
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