AccessGUDID - DEVICE: DEPTHALON® (00650551070337)

GUDID

Device Identifier (DI) Information

Brand Name: DEPTHALON®
Version or Model: 2102-06-IL-SS-M2-NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2102-06-IL-SS-M2-NS
Company Name: PMT CORPORATION

Primary DI Number: 00650551070337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2

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":	Yes
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?
32556	Depth electrode	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151790	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Contact Length 5 Millimeter
Device Size Text, specify: Main Tube Length 32 Centimeter
Device Size Text, specify: Spacing 10 Millimeter
Device Size Text, specify: Recording Depth 55 Millimeter

Device Record Status

Public Device Record Key: cc5f81ee-c563-4ce2-b63d-0f5756d77d73
Public Version Date: September 23, 2019
Public Version Number: 4
DI Record Publish Date: January 05, 2017