Identity
- Trade Name
- Rospital Productos Medicos FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 3ML SYRINGE/NEEDLE COMBINATION LUER-LOCK TIP 25 G X 5/8 IN. EA. FDA UDI
- Model / Reference
- SY325 FDA UDI
- Description
- 3ML SYRINGE/NEEDLE COMBINATION LUER-LOCK TIP 25 G X 5/8 IN. EA. FDA UDI
Identifiers
- Catalog Number
- SY325 FDA UDI
- Primary DI / UDI-DI
- 00812460026939 FDA UDI
- 510(k) Number
- K060211 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use 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
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-useGeneral-purpose syringe, single-use
Rospital Productos Medicos by Atlas Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Cleared under the same submission
K060211 also covers:
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
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
- Atlas Medical Products Llc
Sources (1)
- FDA UDI 4141ae4a-44b2-4c1e-b592-e7fc88442f00 37 fields · synced May 30, 2026