FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoQuest
DI: 00840326406328
·
Model: L0171
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- OrthoQuest
- Primary DI
- 00840326406328
- Version / Model
- L0171
- Catalog Number
- L0171
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 9995d7d2-353d-42c0-9fc4-196743ff68c4
Device Description
PULL HEAD CAP RED LARGE
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
- 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 |
|---|---|---|---|---|
| DZB | Headgear, extraoral, orthodontic | Dental | 872.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41067 | Orthodontic chin cap/cup | A dental device component of an extraoral orthodontic headgear designed to help reduce/correct mandibular prognathism by applying reverse pull force to the chin, via tight attachment to the headgear head straps. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840326406325 | GS1 | Inner | 5 | In Commercial Distribution | |
| Primary | 00840326406328 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961754 | 000 |