AccessGUDID - DEVICE: SaliPen (07290014891005)

GUDID

Device Identifier (DI) Information

Brand Name: SaliPen
Version or Model: OTC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SALIWELL LTD

Primary DI Number: 07290014891005
Issuing Agency: GS1
Commercial Distribution End Date: July 17, 2033
Device Count: 1
Labeler D-U-N-S® Number*: 533732749 *Terms of Use

Device Description: SaliPen is an electrostimulating device aimed at treating dry mouth.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
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?
58162	Dry mouth saliva electrical stimulator	A battery-powered device intended to apply electrical current directly to the soft tissue in the mouth of a patient to stimulate a sensorial nerve for increased secretion of saliva from the salivary glands to treat dry mouth condition (xerostomia). It passes a low electric current pulse-train via its integrated electrodes intended to generate an electromagnetic (EM) field around the targeted nerve. The device is activated by the patient with an integrated control or included remote control. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTT	Over The Counter Electrical Salivary Stimulatory System

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd2d8f04-b436-4ddd-94ea-164e2924dd2f
Public Version Date: July 11, 2024
Public Version Number: 1
DI Record Publish Date: July 03, 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES