FDA UDI In Commercial Distribution 🇺🇸 United States

Howard Leight

DI: 00033552017769 · Model: MAX USA · SPERIAN HEARING PROTECTION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Howard Leight
Primary DI
00033552017769
Version / Model
MAX USA
Catalog Number
R-01776
Company Name
SPERIAN HEARING PROTECTION, LLC
Labeler DUNS
014982953
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-31
Public Version
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
be26b8ee-db57-42b2-bef0-4d48c120ae28

Device Description

Shooting Sports Patriotic Kit. Kit includes one pair of shooting glasses and 10 pairs of earplugs.

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
EWD Protector, Hearing (Insert)

GMDN Terms

Code Name
35024 Earplugs, single-use

Identifiers

Type ID
Primary 00033552017769