FDA UDI
In Commercial Distribution
🇺🇸 United States
Uline Bullet Earplugs - Uncorded
DI: 10851253007486
·
Model: S-17902
·
ULINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Uline Bullet Earplugs - Uncorded
- Primary DI
- 10851253007486
- Version / Model
- S-17902
- Catalog Number
- S-17902
- Company Name
- ULINE, INC.
- Labeler DUNS
- 039612668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2019-02-07
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 76f285f0-8a43-4d76-bceb-f9120175a8d4
Device Description
200 pairs of uncorded earplugs
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 | 30851253007480 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10851253007486 | GS1 | ||||
| Unit of Use | 00851253007489 | GS1 |