Identity
- Trade Name
- Forsure FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device. NLXZ Hypodermic needle, single-use, sterile FDA UDI
- Model / Reference
- 90018150 FDA UDI
- Description
- A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device. NLXZ Hypodermic needle, single-use, sterile FDA UDI
Identifiers
- Catalog Number
- 90018150 FDA UDI
- Primary DI / UDI-DI
- 00897633001012 FDA UDI
- 510(k) Number
- K112057 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Inch FDA UDINeedle Gauge — 18 Gauge FDA UDI
Category: Hypodermic needle, single-use
Forsure by Forsure Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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Cleared under the same submission
K112057 also covers:
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
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
- Forsure Medical Products Llc
Sources (1)
- FDA UDI 73026963-190f-4720-b3cf-1a55bd635967 37 fields · synced May 30, 2026