Identity
- Trade Name
- DropSafe Syringe with Safety Needle FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication. FDA UDI
- Model / Reference
- 3mL 25Gx1” FDA UDI
- Description
- Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication. FDA UDI
Identifiers
- Catalog Number
- 6072 FDA UDI
- Primary DI / UDI-DI
- 05903999600310 FDA UDI
- 510(k) Number
- K101359 FDA UDI
- FDA Product Code
- FMF FDA UDIFMI FDA UDI
- GMDN Term
- General-purpose syringe/needle 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: General-purpose syringe/needleNeedle guard
DropSafe Syringe with Safety Needle by Htl Strefa S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guard.
- SOL-CARE™ Safety Blood Collection Needle — Sol-Millennium Medical, Inc. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- EasyPoint® — Retractable Technologies, Inc. · Class II
- Portex — ICU MEDICAL, INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- SOL-CARE™ Luer Lock Syringe with Safety Needle — Sol-Millennium Medical, Inc. · Class II
- SOL-CARE™ Luer Lock Syringe with Safety Needle — Sol-Millennium Medical, Inc. · Class II
Cleared under the same submission
K101359 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 7a2c03cf-50ac-498d-87a2-8fb8948b5d70 36 fields · synced May 30, 2026