FDA UDI In Commercial Distribution 🇺🇸 United States

Howard Leight by Honeywell

DI: 00033552000242 · Model: AIRSOFT · SPERIAN HEARING PROTECTION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Howard Leight by Honeywell
Primary DI
00033552000242
Version / Model
AIRSOFT
Catalog Number
AS-1
Company Name
SPERIAN HEARING PROTECTION, LLC
Labeler DUNS
014982953
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-22
Public Version
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
e594daf8-37a1-4e20-ad1a-7ffe205ec46d

Device Description

AirSoft Multiple-Use Earplug

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EWE Protector, Hearing (Circumaural)

GMDN Terms

Code Name
35024 Earplugs, single-use

Identifiers

Type ID
Primary 00033552000242