FDA UDI
In Commercial Distribution
🇺🇸 United States
Spark
DI: 00681131145855
·
Model: 26201
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Spark
- Primary DI
- 00681131145855
- Version / Model
- 26201
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 953facf4-17b8-4f5d-b6b0-4efcd13df5ba
Device Description
Waterfilled Fish Teethers
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | Dental | 872.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44272 | Teething device, fluid-filled | A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00681131145855 | GS1 | ||||
| Unit of Use | 01681131145855 | GS1 |