Identity
- Trade Name
- MT FDA UDI
- Generic Name
- Submucosal injection needle FDA UDI
- Device Name
- POM inner tuber,Needle Length 6mm,with metal cap 25G*6*1.8*230,Shroat stucture FDA UDI
- Model / Reference
- IN12-256182302 FDA UDI
- Description
- POM inner tuber,Needle Length 6mm,with metal cap 25G*6*1.8*230,Shroat stucture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503533430 FDA UDI
- 510(k) Number
- K150434 FDA UDI
- FDA Product Code
- FBK FDA UDI
- GMDN Term
- Submucosal injection needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mt by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150434 also covers:
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 48cb4bb7-064a-42fb-92ad-4009767a9ac1 35 fields · synced Jun 8, 2026