Identity
- Trade Name
- LDV Syringe 1mL/cc x 1FT x FDN3 (23G x 25mm) FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Model / Reference
- 1FT x FDN3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800145513791 FDA UDI
- 510(k) Number
- K092831 FDA UDI
- FDA Product Code
- QNQ FDA UDIFMI FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 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/needle
LDV Syringe 1mL/cc x 1FT x FDN3 (23G x 25mm) by Feeltech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092831 also covers:
- ELASTY Mesoneedle — Feeltech Co., Ltd.
- ELASTY Mesoneedle — Feeltech Co., Ltd.
- ELASTY Mesoneedle 33Gx8mm — Feeltech Co., Ltd.
- ELASTY Mesoneedle 34Gx8mm — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech Co., Ltd.
- ELASTY Micro Cannula — Feeltech 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Feeltech Co., Ltd.
Sources (1)
- FDA UDI b84e5fff-83bf-4e74-b18d-a787a0d30f40 33 fields · synced May 30, 2026