FDA UDI
In Commercial Distribution
🇺🇸 United States
Orthoquest
DI: 00840326408568
·
Model: G010
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Orthoquest
- Primary DI
- 00840326408568
- Version / Model
- G010
- Catalog Number
- G010
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-03
- Public Version
- 1
- Public Version Date
- 2022-11-11
- Public Version Status
- New
- Public Device Record Key
- 38f6de58-907e-40b5-9096-d4dd31c0326a
Device Description
Direct Bond Bracket Remover
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31801 | Orthodontic metal band pusher | A hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840326408565 | GS1 | Inner Pack | 1 | In Commercial Distribution | |
| Primary | 00840326408568 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]