FDA UDI
In Commercial Distribution
🇺🇸 United States
DTC
DI: 06973554430576
·
Model: M305
·
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
- 06973554430576
- Version / Model
- M305
- 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
- e99b058d-f1d3-42e3-930b-ba3261a7a8a5
Device Description
Stainless steel mirror
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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973554430576 | GS1 |