FDA.report

Spencer Probe Depth Electrode

Primary DI
00841823100412
Brand
Spencer Probe Depth Electrode
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
AD08R-SP05X-000
Catalog number
AD08R-SP05X-000
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GZLELECTRODE, DEPTH

Product Code Classifications

CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841823100412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823100412008418231004128418231004120841823100412

GMDN Terms

TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags

DUNS number
174813410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00841823110848Ad-Tech Macro Depth ElectrodeSR12R-SP05X-0BHSR12R-SP05X-0BH2026-02-23
00841823110855Ad-Tech Macro Depth ElectrodeSR08R-SP05X-0BHSR08R-SP05X-0BH2026-02-23
00841823110862Ad-Tech Macro Depth ElectrodeSR08R-SP21X-0C3SR08R-SP21X-0C32026-02-23
00841823110879Ad-Tech Macro Depth ElectrodeSR08R-SP61X-0C3SR08R-SP61X-0C32026-02-23
00841823110886Ad-Tech Macro Depth ElectrodeSR10R-SP05X-0BHSR10R-SP05X-0BH2026-02-23
00841823110893Ad-Tech Macro Depth ElectrodeSR10R-SP21X-0C3SR10R-SP21X-0C32026-02-23
00841823110909Ad-Tech Macro Depth ElectrodeSR10R-SP61X-0C3SR10R-SP61X-0C32026-02-23
00841823110916Ad-Tech Macro Depth ElectrodeSR12R-SP21X-0C3SR12R-SP21X-0C32026-02-23
00841823110923Ad-Tech Macro Depth ElectrodeSR12R-SP61X-0C3SR12R-SP61X-0C32026-02-23
00841823109996SIGNUM Connection System Cable1L-JBL-2DIN2025-12-09
00841823110008SIGNUM Connection System Cable1L-JBL-4DIN2025-12-09
00841823110015SIGNUM Connection System Cable1L-JBL-6DIN2025-12-09
00841823110039SIGNUM Connection System Cable1L-JBL-8DIN2025-12-09
00841823110053SIGNUM Connection System Cable1L-JBL-10DIN2025-12-09
00841823110060SIGNUM Connection System Cable1L-JBL-12BDIN2025-12-09
00841823110077SIGNUM Connection System Cable1L-JBL-14BDIN2025-12-09
00841823110084SIGNUM Connection System Cable1L-JBL-16DIN2025-12-09
00841823110091SIGNUM Connection System Cable1L-JBL-16BDIN2025-12-09
00841823110107SIGNUM Connection System Cable1L-JBL-20DIN2025-12-09
00841823110114SIGNUM Connection System Cable1L-JBL-24BDIN2025-12-09

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00841823110862Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
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00841823110893Ad-Tech Macro Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-02-23
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