FDA UDI
In Commercial Distribution
🇺🇸 United States
RIVA CONDITIONER
DI: 09336472016760
·
Model: 8620001
·
SDI LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RIVA CONDITIONER
- Primary DI
- 09336472016760
- Version / Model
- 8620001
- Catalog Number
- 8620001
- Company Name
- SDI LIMITED
- Labeler DUNS
- 753221852
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-08
- Public Version
- 2
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 42be46dd-fa94-4a32-bc2d-74f0a88838df
Device Description
RIVA CONDITIONER 10ML PK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36153 | Dental tooth-etching solution | An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09336472016760 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990650 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage conditions 10°C - 25°C (50 - 77°F)