AccessGUDID - DEVICE: Blue Silicast Hardener (00850047788436)

GUDID

Device Identifier (DI) Information

Brand Name: Blue Silicast Hardener
Version or Model: NA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10402
Company Name: Westone Laboratories, Inc.

Primary DI Number: 00850047788436
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 007087497 *Terms of Use

Device Description: Blue Silicast Hardener

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):	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?
44974	Earmould impression material	A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDG	Kit, Earmold, Impression

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: 499d4b55-c6a3-4f1a-ad65-8083511972ef
Public Version Date: October 23, 2025
Public Version Number: 2
DI Record Publish Date: August 25, 2023