FDA UDI
In Commercial Distribution
🇺🇸 United States
ULINE BULLET EARPLUGS REFILL
DI: 10850015055703
·
Model: S-25946
·
ULINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
600
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Basic Information
- Brand Name
- ULINE BULLET EARPLUGS REFILL
- Primary DI
- 10850015055703
- Version / Model
- S-25946
- Company Name
- ULINE, INC.
- Labeler DUNS
- 039612668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 600
- Record Status
- Published
- Publish Date
- 2024-05-13
- Public Version
- 1
- Public Version Date
- 2024-05-21
- Public Version Status
- New
- Public Device Record Key
- 12297496-3cd6-4c0a-9195-144a65ae40b4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| EWD | Protector, Hearing (Insert) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35024 | Earplugs, single-use | A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850015055493 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10850015055703 | GS1 | ||||
| Unit of Use | 00850015055706 | GS1 |