AccessGUDID - DEVICE: Mack's (00033732002066)

GUDID

Device Identifier (DI) Information

Brand Name: Mack's
Version or Model: Pillow Soft Silicone Putty Earplug Dispenser (Orange)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 206
Company Name: McKeon Products, Inc.

Primary DI Number: 00033732002066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 006522122 *Terms of Use

Device Description: Moldable Silicone Earplugs (Orange) - 200-pair Dispenser

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?
41230	Earplugs, reusable	A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWD	Protector, Hearing (Insert)

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: e3f51196-712b-4c86-81cc-bb10645de6bd
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022