FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lamaze
DI: B268L276190
·
Model: L27619
·
TOMY INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Lamaze
- Primary DI
- B268L276190
- Version / Model
- L27619
- Catalog Number
- L27619
- Company Name
- TOMY INTERNATIONAL, INC.
- Labeler DUNS
- 065183758
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-01
- Public Version
- 4
- Public Version Date
- 2025-06-20
- Public Version Status
- Update
- Public Device Record Key
- 7c3fc839-46d7-4cf6-a244-cc0f680efc75
- Distribution End Date
- 2025-01-01
Device Description
Water Filled Chill 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | B268L276198 | HIBCC | Master | 4 | Not in Commercial Distribution | 2025-01-01 |
| Package | B268L276192 | HIBCC | Retail | 2 | Not in Commercial Distribution | 2025-01-01 |
| Primary | B268L276190 | HIBCC | ||||
| Package | B268L276199 | HIBCC | Master | 3 | Not in Commercial Distribution | 2025-01-01 |