DEVICE: Ambu Subdermal CorkscrewSingle Patient Probes (05707480107599)

Device Identifier (DI) Information

Ambu Subdermal CorkscrewSingle Patient Probes
74715-60/24
In Commercial Distribution
74715-60/24
Ambu A/S
05707480107599
GS1

1
305682023 *Terms of Use
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) Min. order is 24 pcs. = 1 box
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Subdermal needle electrode A 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.
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FDA Product Code

[?]
Product Code Product Code Name
GXZ Electrode, Needle
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 120 Centimeter
Length: 47 Inch
Lumen/Inner Diameter: 0.60 Millimeter
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Device Record Status

f07c3e9c-7fbc-4e8b-b604-48b5d486162d
July 11, 2018
4
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480107612 48 05707480107605 In Commercial Distribution
05707480107605 24 05707480107599 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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