FDA.report

Ambu Subdermal CorkscrewSingle Patient Probes

Primary DI
05707480107612
Brand
Ambu Subdermal CorkscrewSingle Patient Probes
Company
Ambu A/S
Model
74715-60/24
Catalog number
74715-60/24
Device description
Ambu IOM Corkscrew Needle 747 For EEG or EP monitoring during surgery. Disposable, with 6 lead wire colours (red, black, blue, yellow, white and green
Published
2016-09-21
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
GXZElectrode, Needle

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480107605PackageGS124In Commercial Distribution
05707480107612PackageGS148In Commercial Distribution
05707480107599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480107605057074801076055707480107605
05707480107612057074801076125707480107612
05707480107599057074801075995707480107599

GMDN Terms

TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Device Sizes

TypeValueUnit
Length47Inch
Length120Centimeter
Lumen/Inner Diameter0.6Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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