Identity
- Trade Name
- DropSafe Safety Needle LD FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- The Dropsafe® Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin. FDA UDI
- Model / Reference
- 23G x 1" FDA UDI
- Description
- The Dropsafe® Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin. FDA UDI
Identifiers
- Catalog Number
- 6069 FDA UDI
- Primary DI / UDI-DI
- 05907996099962 FDA UDI
- 510(k) Number
- K123684 FDA UDI
- FDA Product Code
- FMF FDA UDIFMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use 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
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 Safety Needle LD by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
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- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
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Cleared under the same submission
K123684 also covers:
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
- Htl Strefa S A
Sources (1)
- FDA UDI 88117cb2-aa6a-4ad6-9b58-2b0427fc783b 36 fields · synced May 31, 2026