AccessGUDID - DEVICE: Howard Leight (07312550119945)

GUDID

Device Identifier (DI) Information

Brand Name: Howard Leight
Version or Model: L1N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1011994-H5
Company Name: SPERIAN HEARING PROTECTION, LLC

Primary DI Number: 07312550119945
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 014982953 *Terms of Use

Device Description: EARMUFF,LEIGHTNING L1N,NECKBND

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?
41232	Acoustic earmuffs	A device that is worn over the ears to protect the user's hearing from excessive levels of noise, typically when using noisy machinery. It consists of a two hard plastic cups (one to fit over each ear) that are lined with sound attenuating material with soft ear cushions/pads on the outer rim. The cups are held together with a headband that is sprung to gently hold the cups against the side of the head. Included are types that also provide warmth and which are used for cold outdoor weather conditions. Also known as ear defenders. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWE	Protector, Hearing (Circumaural)

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
Special Storage Condition, Specify: -20C to 60C <90% Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77b4d7af-add1-4b58-9538-88f10e9b6773
Public Version Date: August 10, 2020
Public Version Number: 1
DI Record Publish Date: July 31, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 17312550119942 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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