FDA UDI
In Commercial Distribution
🇺🇸 United States
DTC
DI: 06973554430552
·
Model: A212
·
Hangzhou DTC Medical Apparatus Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
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
- DTC
- Primary DI
- 06973554430552
- Version / Model
- A212
- Company Name
- Hangzhou DTC Medical Apparatus Co., Ltd.
- Labeler DUNS
- 525905364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-06
- Public Version
- 2
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 34d46e51-b7ca-47ce-879f-76212130c87d
Device Description
Force gauge
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
- MR Unsafe
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JEX | Plier, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44861 | Orthodontic appliance force gauge | A hand-held dental instrument intended to be used in orthodontics to accurately measure forces (in grams or ounces) applied by the elastics or springs used when setting up orthodontic appliances within the patient's mouth. The device is typically of cylindrical or tubular design (but can be dial-shaped with circular read out) and is made of metal (some partly plastic); it contains a spring-loaded mechanism which indicates the force exerted to pull the appliance elastic or spring to the desired length. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973554430552 | GS1 |