Identity
- Trade Name
- Shifeng FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Model / Reference
- UUSF1LL FDA UDI
Identifiers
- Primary DI / UDI-DI
- G002UUSF1LL0 FDA UDI
- 510(k) Number
- K132553 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Category: General-purpose syringe, single-use
Shifeng by Shifeng Medical Technology Co.，ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132553 also covers:
- Lite Touch — AMITY HOLDINGS, LLC
- LiteTouch — AMITY HOLDINGS, LLC
- LiteTouch — AMITY HOLDINGS, LLC
- LiteTouch — AMITY HOLDINGS, LLC
- LiteTouch — AMITY HOLDINGS, LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shifeng Medical Technology Co.，ltd.
Sources (1)
- FDA UDI 4ce2a02e-f5de-478f-96a5-b68bb38d1705 33 fields · synced Jun 8, 2026