FDA UDI
In Commercial Distribution
🇺🇸 United States
tippy toes by TopCare
DI: 00036800400245
·
Model: 63250TC
·
TOPCO ASSOCIATES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- tippy toes by TopCare
- Primary DI
- 00036800400245
- Version / Model
- 63250TC
- Company Name
- TOPCO ASSOCIATES, LLC
- Labeler DUNS
- 072943876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-10
- Public Version
- 1
- Public Version Date
- 2020-08-18
- Public Version Status
- New
- Public Device Record Key
- 841ed11e-8a05-4911-9f60-8d339491a528
Device Description
TC NUBBY TEETHER
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MEF | Ring, Teething, Non-Fluid Filled | Dental | 872.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44258 | Teething device, non-fluid-filled | A circular or cylindrical device free of fluid and 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 |
|---|---|---|---|---|---|---|
| Package | 20025715033543 | GS1 | Bag | 6 | In Commercial Distribution | |
| Primary | 00036800400245 | GS1 | ||||
| Package | 10036800400242 | GS1 | Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]