FDA UDI
In Commercial Distribution
🇺🇸 United States
GRADIA®
DI: D6584000081
·
Model: 400008
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GRADIA®
- Primary DI
- D6584000081
- Version / Model
- 400008
- Catalog Number
- 400008
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6e938a59-1768-4db5-a554-7749e8092bb7
Device Description
GRADIA® GC FIBER POST Drill Refills, 1 drill of one size, Diameter 1.4
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DZA | DRILL, DENTAL, INTRAORAL | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38609 | Root canal post, preformed | A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6584000081 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean and dry area.