AccessGUDID - DEVICE: FLENTS PROTECHS (00023185081503)

GUDID

Device Identifier (DI) Information

Brand Name: FLENTS PROTECHS
Version or Model: F408-150/F408-150ST/F408-150WM1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APOTHECARY PRODUCTS, LLC

Primary DI Number: 00023185081503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 092312735 *Terms of Use

Device Description: 150 QUIET! PLEASE 10 PR 150 QP 10 PR E/P IN SHELF TRAY

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?
35024	Earplugs, single-use	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 single-use 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: bce22d9a-ddd1-47c3-8118-e236bc641477
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: October 13, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20023185081507	6	00023185081503	In Commercial Distribution	inner
10023185081500	12	20023185081507	In Commercial Distribution	case
20023185025488	6	00023185081503	In Commercial Distribution	inner
10023185604259	4	20023185025488	In Commercial Distribution	case
20025715034786	3	00023185081503	In Commercial Distribution	inner
10025715039296	8	20025715034786	In Commercial Distribution	case