FDA UDI
In Commercial Distribution
🇺🇸 United States
MT
DI: 06932503562010
·
Model: DYZ-04-15
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MT
- Primary DI
- 06932503562010
- Version / Model
- DYZ-04-15
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-28
- Public Version
- 1
- Public Version Date
- 2023-07-06
- Public Version Status
- New
- Public Device Record Key
- 7a143f7a-75f2-40b6-8b47-9b2d0e55ffcd
Device Description
Product is dark blue solution, the concentration is 0.4%, the content is 15ml. Initial packaging is the vial.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBG | Marker, Colon | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17828 | Tissue marking ink | A sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503562017 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 06932503562010 | GS1 | ||||
| Package | 26932503562014 | GS1 | CASE | 10 | In Commercial Distribution |