AccessGUDID - DEVICE: sTMS mini (00816140020125)

GUDID

Device Identifier (DI) Information

Brand Name: sTMS mini
Version or Model: DWG-0501-SG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWG-0501-SG
Company Name: ENEURA, INC.,

Primary DI Number: 00816140020125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013665656 *Terms of Use

Device Description: Transcranial Magnetic Stimulator Device

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?
62219	Home-use magnetic neural stimulator	A rechargeable battery-powered device intended to be used for the treatment of pain associated with migraine headache (with or without aura) through noninvasive transcranial magnetic stimulation (TMS) of the brain. It is a hand-held unit intended to be placed at the base of the skull at the earliest onset of symptoms of a migraine headache, to reduce or stop the effects of migraine headache, through generation of a single pulse magnetic field. It is typically programmed to deliver treatment in accordance with a specific patient prescription and is intended to be used in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OKP	Transcranial magnetic stimulator for the treatment of migraine headache

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161663	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 Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d62321e3-52f8-47cb-9b36-08049dade095
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 22, 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(408)245-6400 ext: 126
Email: Customercare@eneura.com

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