AccessGUDID - DEVICE: SALVAASAICHIN (04987603331969)

GUDID

Device Identifier (DI) Information

Brand Name: SALVAASAICHIN
Version or Model: 33196
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4987603331969
Company Name: HAKUJUJI CO., LTD.

Primary DI Number: 04987603331969
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 690868054 *Terms of Use

Device Description: Ate-Raku Pads, Night Use, One Pad Until Morning, 26 pieces per pack

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:	Yes
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?
35817	Incontinence pants liner	A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYQ	Garment, Protective, For Incontinence

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fbae9a2c-12f8-4580-b242-65a7e01a2855
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: July 12, 2024