AccessGUDID - DEVICE: Therabionic P1 (04251867200119)

GUDID

Device Identifier (DI) Information

Brand Name: Therabionic P1
Version or Model: 02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: THBC P1-PS-02
Company Name: TheraBionic GmbH

Primary DI Number: 04251867200119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312894281 *Terms of Use

Device Description: AC power supply unit, 15W for the TheraBionic P1 - Variant 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":	No
For Single-Use:	No
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?
58847	Alternating electric field antimitotic cancer treatment system generator	A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOM	Stimulator, Electric Field, Intrabuccal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H220001	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Temperature range of -20°C - +60°C, humidity range of 0% - 90%, pressure range of 700hPa - 1200 hPa

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e821839b-07e5-4faa-83b3-e5572265a517
Public Version Date: May 02, 2024
Public Version Number: 1
DI Record Publish Date: April 24, 2024

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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 312 286 4703
Email: boris.pasche@therabionic.de

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES