Identity
- Trade Name
- TopCare Clickfine Pen Needles FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length FDA UDI
- Model / Reference
- 700001340 FDA UDI
- Description
- Sterile, single-use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800250918 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
FDA UDI
Over-the-Counter
Yes
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 — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
TopCare Clickfine Pen Needles by Topco Associates, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Topco Associates, LLC
Sources (1)
- FDA UDI 8f73243c-b697-4373-98f5-a6f2b3548260 35 fields · synced May 31, 2026