Identity
- Trade Name
- 0.5ml Suresafe Syringe FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe/needle FDA UDI
- Device Name
- 0.5ml Suresafe Manual Retractable Syringe - 29G x 1/2" FDA UDI
- Model / Reference
- 0.5ml Syringe 29G x 1/2" FDA UDI
- Description
- 0.5ml Suresafe Manual Retractable Syringe - 29G x 1/2" FDA UDI
Identifiers
- Catalog Number
- FD-MSSFX005-29 FDA UDI
- Primary DI / UDI-DI
- 05391530750691 FDA UDI
- 510(k) Number
- K141349 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metered-delivery hypodermic syringe/needle
0.5ml Suresafe Syringe by Dmc Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe/needle.
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- Magellan — Cardinal Health 200, LLC · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- BD Integra — BECTON DICKINSON AND COMPANY · Class II
- VanishPoint® — Retractable Technologies, Inc. · Class II
- Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag · Class II
- Safety Syringe w/Needle — Dynarex Corp. · Class II
Cleared under the same submission
K141349 also covers:
- 0.5ml Insulin - Suresafe Manual Retractable Syringe — DMC MEDICAL LIMITED
- 10ml Suresafe Manual Retractable Syringe 21G x 1 1/2" — DMC MEDICAL LIMITED
- 1ml Insulin Suresafe Manual Retractable Syringe 29G x 1/2" — DMC MEDICAL LIMITED
- 1ml Insulin Suresafe Syringe — DMC MEDICAL LIMITED
- 1ml Suresafe Manual Retractable Syringe 25G x 1" — DMC MEDICAL LIMITED
- 1ml Tuberculin Suresafe Manual Retractable Syringe 27G x 1/2" — DMC MEDICAL LIMITED
- 1ml Tuberculin Suresafe Syringe — DMC MEDICAL LIMITED
- 1ml Tuberculin Suresafe Syringe — DMC MEDICAL LIMITED
- 1ml Tuberculin Suresafe Syringe — DMC MEDICAL LIMITED
- 3ml Suresafe Manual Retractable Syringe 25G x 1" — DMC MEDICAL LIMITED
- 5ml Suresafe Manual Retractable Syringe 22G x 1 1/2" — DMC MEDICAL LIMITED
- Suresafe 1ml Syringe — DMC MEDICAL LIMITED
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
- Dmc Medical Limited
Sources (1)
- FDA UDI a41e2a7c-b4c6-4494-8bb4-904b6639227b 35 fields · synced Jun 6, 2026