FDA UDI
In Commercial Distribution
🇺🇸 United States
Quick-Detect
DI: D2486056621
·
Model: 605662
·
HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
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Basic Information
- Brand Name
- Quick-Detect
- Primary DI
- D2486056621
- Version / Model
- 605662
- Company Name
- HAGER WORLDWIDE, INC.
- Labeler DUNS
- 009277971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2025-10-20
- Public Version
- 1
- Public Version Date
- 2025-10-28
- Public Version Status
- New
- Public Device Record Key
- 566ed809-8851-4728-a010-717ce26b6c86
Device Description
Plaque disclosing pre-saturated swabs
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 |
|---|---|---|---|---|
| QJC | Plaque Disclosing Agent | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60408 | Dental caries detecting stain | A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D2486056620 | HIBCC | ||||
| Primary | D2486056621 | HIBCC |