FDA UDI
In Commercial Distribution
🇺🇸 United States
digit® Targeted Delivery System
DI: D0026780201
·
Model: 678020
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- digit® Targeted Delivery System
- Primary DI
- D0026780201
- Version / Model
- 678020
- Catalog Number
- 678020
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-04-19
- Public Version
- 1
- Public Version Date
- 2022-04-27
- Public Version Status
- New
- Public Device Record Key
- 9c7a6e8b-8fb2-4179-9d9b-b307f2b7db17
Device Description
digit® Syringe Dispenser Refill
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
- 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 |
|---|---|---|---|---|
| EHZ | Evacuator, oral cavity | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62681 | Dental material cartridge-plunging applicator, two-component, electric | An electrically-powered device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is a handpiece with an electric cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D0026780200 | HIBCC | ||||
| Primary | D0026780201 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store digit® syringe at room temperature.