AccessGUDID - DEVICE: Silk'n (17290112450064)

GUDID

Device Identifier (DI) Information

Brand Name: Silk'n
Version or Model: Tightra NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7290112450067
Company Name: HOME SKINOVATIONS LTD

Primary DI Number: 17290112450064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514891048 *Terms of Use

Device Description: No description.

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):	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?
33728	Penile sexual vibrator	A noninvasive, electronic device intended to use vibratory stimuli to facilitate male orgasm and/or ejaculation, including for the treatment/control of male sexual disorders (e.g., premature ejaculation); it does not include sexual lubricant or additional accessory devices. It may be used in the presence of a limiting disability, such as spinal cord injury. It may also be used as an adjunct in the treatment of tightening the muscles of the pelvic floor to increase muscle tone (Kegel's exercise).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXQ	Vibrator For Therapeutic Use, Genital

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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08e540a6-47f6-4fd4-94bb-a18429b8c836
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: November 04, 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
37290112450068	1	17290112450064		In Commercial Distribution	Box
27290112450061	4	17290112450064		In Commercial Distribution	Box

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: Yes
DM DI Number: 07290112450067
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: 1-877-367-4556
Email: contact@silkn.com

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

FDA TOOLS & RESOURCES