FDA UDI
In Commercial Distribution
🇺🇸 United States
GELATO
DI: H66824023771
·
Model: 24-02377
·
Keystone Industries
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- GELATO
- Primary DI
- H66824023771
- Version / Model
- 24-02377
- Catalog Number
- 24-02377
- Company Name
- Keystone Industries
- Labeler DUNS
- 073503117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 94a84c60-9475-46a0-86ba-e6a8849e11a6
Device Description
PROPHY PASTE CUPS MED BUBBLE X200
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11168 | Dentifrice | A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | H66824023770 | HIBCC | ||||
| Primary | H66824023771 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 14.1 | Fluid Ounce | |
| Weight | 400 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight