FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Green Sprouts
DI: 00715418154688
·
Model: 385632-001-33
·
O2cool, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Green Sprouts
- Primary DI
- 00715418154688
- Version / Model
- 385632-001-33
- Company Name
- O2cool, LLC
- Labeler DUNS
- 004603413
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-01
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- cc04f96d-447b-4a06-82de-1527028240dd
- Distribution End Date
- 2021-06-01
Device Description
Silicone Ring Teether-0/6mo
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00715418154688 | GS1 |