Identity
- Trade Name
- DropSafe Sicura FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- PASSIVE SAFETY NEEDLE DROPSAFE SICURA G21x25mm 50p FDA UDI
- Model / Reference
- 02094000210250 FDA UDI
- Description
- PASSIVE SAFETY NEEDLE DROPSAFE SICURA G21x25mm 50p FDA UDI
Identifiers
- Catalog Number
- 02094000210250 FDA UDI
- Primary DI / UDI-DI
- 00812383030914 FDA UDI
- 510(k) Number
- K223353 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
Category: Hypodermic needle, single-use
DropSafe Sicura by Pikdare Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223353 also covers:
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
- DropSafe Sicura — PIKDARE SPA
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
- Pikdare Spa
Sources (1)
- FDA UDI 01b69aa6-ce0f-4183-a0ac-c541e4d2e7f8 36 fields · synced May 30, 2026