AccessGUDID - DEVICE: Henry Schein (00304040019313)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 9004210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9004210
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040019313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Earloop Mask

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Surgical face mask, single-use	A device intended to be placed over the nose and mouth of medical personnel to prevent the transmission of airborne organisms during surgery or patient examination. It is made of a flexible porous fabric material that allows the user to breath normally through the mask and typically includes a metal wire along one border to form fit the nose bridge; it is typically held in place with ties that fasten at the back of the user's head. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Surgical face mask, single-use

A device intended to be placed over the nose and mouth of medical personnel to prevent the transmission of airborne organisms during surgery or patient examination. It is made of a flexible porous fabric material that allows the user to breath normally through the mask and typically includes a metal wire along one border to form fit the nose bridge; it is typically held in place with ties that fasten at the back of the user's head. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FXX	Mask, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at cool dry place. Avoid excessive heat 40C or 104F

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4291e4f5-5fef-4ecc-be56-5f90a9eb2fec
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016