FDA UDI
In Commercial Distribution
🇺🇸 United States
Garg
DI: D943G16010
·
Model: G1601
·
Power Dental U.S.A. Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Garg
- Primary DI
- D943G16010
- Version / Model
- G1601
- Catalog Number
- G1601
- Company Name
- Power Dental U.S.A. Inc.
- Labeler DUNS
- 081305064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-28
- Public Version
- 1
- Public Version Date
- 2023-03-08
- Public Version Status
- New
- Public Device Record Key
- ab9b0eac-db51-410f-b29a-1597a8b67b34
Device Description
CURETTES GRACEY GR1/2
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
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMN | Scaler, Periodontic | Dental | 872.4565 | 1 |
| EMK | Curette, Surgical, Dental | Dental | 872.4565 | 1 |
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41660 | Periodontal curette | A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D943G16010 | HIBCC |
Customer Contacts
- Phone
- +1(800)286-1635
- [email protected]