FDA UDI
In Commercial Distribution
🇺🇸 United States
Howard Leight
DI: 00033552015260
·
Model: Impact Sport
·
SPERIAN HEARING PROTECTION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Howard Leight
- Primary DI
- 00033552015260
- Version / Model
- Impact Sport
- Catalog Number
- R-01526
- Company Name
- SPERIAN HEARING PROTECTION, LLC
- Labeler DUNS
- 014982953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 1
- Public Version Date
- 2020-08-10
- Public Version Status
- New
- Public Device Record Key
- 2cc38092-7929-45bd-a32e-b39bf57b5b72
Device Description
Impact Sport Sound Amplification Electronic Earmuff, Hunter Green
Device Characteristics
- Single Use
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWE | Protector, Hearing (Circumaural) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10033552015267 | GS1 | ||||
| Primary | 00033552015260 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -20C to 60C <90% Humidity