Identity
- Trade Name
- Rospital Productos Medicos FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- 10ML SYRINGE/NEEDLE COMBINATION LUER-LOCK TIP 21 G X 1 IN. EA FDA UDI
- Model / Reference
- SY10215 FDA UDI
- Description
- 10ML SYRINGE/NEEDLE COMBINATION LUER-LOCK TIP 21 G X 1 IN. EA FDA UDI
Identifiers
- Catalog Number
- SY10215 FDA UDI
- Primary DI / UDI-DI
- 00812460027059 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Hypodermic needle, 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
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Also classified as General-purpose syringe, single-use.
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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
K222124 also covers:
- Biotroix Healthcare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix HealthCare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix HealthCare Syringes — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare Hypodermic Needles — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare Hypodermic Needles — BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Biotronix Healthcare Hypodermic Needles — BIOTRONIX HEALTHCARE INDUSTRIES INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atlas Medical Products Llc
Sources (1)
- FDA UDI 89bd7282-9e16-4199-b416-b67adb02a56d 37 fields · synced May 30, 2026