AccessGUDID - DEVICE: Thymatron IV (00850298007003)

GUDID

Device Identifier (DI) Information

Brand Name: Thymatron IV
Version or Model: System IV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EDIV
Company Name: SOMATICS, LLC

Primary DI Number: 00850298007003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187194337 *Terms of Use

Device Description: Electroconvulsive Therapy Instrument

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:	No
Prescription Use (Rx):	No
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?
63214	Electroporation therapy system generator	A mains electricity (AC-powered) non-patient-contact component of an electroporation therapy system intended to generate electrical impulses to be used for electroporation, a phenomenon that induces alteration in the structure of cell membranes to increase their permeability and allow molecules that usually cannot enter the cell membrane, such as drugs [electrochemotherapy (ECT)] and genetic materials [electrogenetherapy (EGT)], to reach the cytoplasm. It is a computerized current generator with controls intended to be used with appropriate probes/handpieces/electrodes (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXC	Device, Electroconvulsive Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 22 Pound
Depth: 5.25 Inch
Height: 13 Inch
Width: 18 Inch

Device Record Status

Public Device Record Key: 95c5623a-85fe-45ca-9b63-d6cadb1bcad0
Public Version Date: September 24, 2018
Public Version Number: 1
DI Record Publish Date: August 23, 2018

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 1-847-234-6761
Email: Sales@thymatron.com

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