AccessGUDID - DEVICE: Tone Applicator (07290016633566)

GUDID

Device Identifier (DI) Information

Brand Name: Tone Applicator
Version or Model: AG608499A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG608499A
Company Name: INMODE M.D LTD

Primary DI Number: 07290016633566
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600417351 *Terms of Use

Device Description: Tone Applicator

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?
61169	Transcutaneous electrical stimulation probe	A non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192249	000
K201285	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
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4367c549-55d1-4091-abf8-97d94433d5da
Public Version Date: June 26, 2024
Public Version Number: 2
DI Record Publish Date: October 30, 2022

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: 1-887-367-4556
Email: contact@inmode.com

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