AccessGUDID - DEVICE: Siliclone X-Act 8pk No tips (00850047788016)

GUDID

Device Identifier (DI) Information

Brand Name: Siliclone X-Act 8pk No tips
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10113
Company Name: Westone Laboratories, Inc.

Primary DI Number: 00850047788016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007087497 *Terms of Use

Device Description: Siliclone X-Act 8pk No tips Impression Material Proprietary

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):	No
Kit:	Yes
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
No Product Codes

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: db832c82-c66a-4eb1-bc62-3e6b02da3937
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022