Identity
- Trade Name
- TopFine® FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
- Model / Reference
- TopFine Insulin Pen Needles 31Gx6mm 100pcs FDA UDI
- Description
- Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809445831819 FDA UDI
- 510(k) Number
- K152410 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
Category: Hypodermic needle, single-use
TopFine® by Medexel Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152410 also covers:
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL 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
- Medexel Co., Ltd.
Sources (1)
- FDA UDI 068dba21-7a06-4bea-b70e-c669ccf69951 37 fields · synced May 30, 2026