AccessGUDID - DEVICE: NA (00613994870797)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: NRE1004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00613994870797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: ELECTRODE NRE1004 NEEDLE WITH RING ROHS

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47714	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE
IYN	System, imaging, pulsed doppler, ultrasonic
ITX	Transducer, ultrasonic, diagnostic
GWE	STIMULATOR, PHOTIC, EVOKED RESPONSE
GWQ	Full-montage Standard Electroencephalograph
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061639	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 22.0 Millimeter
Length: 2.0 Meter
Length: 2.5 Meter
Width: 2.0 Centimeter
Length: 13.0 Millimeter
Length: 2.7 Centimeter
Length: 5.0 Centimeter
Needle Gauge: 27.0 Gauge
Width: 3.5 Centimeter

Device Record Status

Public Device Record Key: 64e9b9fc-2f76-4997-84ab-7943440b08f6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 05, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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