FDA UDI
In Commercial Distribution
🇺🇸 United States
IQ Dental
DI: 00816519022569
·
Model: ATI-GG1-6/28
·
IQ DENTAL SUPPLY LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IQ Dental
- Primary DI
- 00816519022569
- Version / Model
- ATI-GG1-6/28
- Catalog Number
- ATI-GG1-6/28
- Company Name
- IQ DENTAL SUPPLY LLC
- Labeler DUNS
- 830702846
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 1
- Public Version Date
- 2023-01-04
- Public Version Status
- New
- Public Device Record Key
- 1c4238fa-b538-4acb-bc5f-2bcd8f39c653
Device Description
ATI Gates Glidden Drills 1-6 Assorted 28mm-Short Pkg/6
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 45697 | Fixture/appliance dental drill bit, single-use | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816519022569 | GS1 |