Identity
- Trade Name
- Med-Syringe FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 10cc Med-Syringe L/L Red-Nitro FDA UDI
- Model / Reference
- 382022 FDA UDI
- Description
- 10cc Med-Syringe L/L Red-Nitro FDA UDI
Identifiers
- Catalog Number
- 382022 FDA UDI
- Primary DI / UDI-DI
- 00886333209439 FDA UDI
- 510(k) Number
- K911732 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Med-Syringe by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K911732 also covers:
- Control Syringe — Argon Medical Devices, Inc.
- Control Syringe — Argon Medical Devices, Inc.
- Control Syringe — Argon Medical Devices, Inc.
- Control Syringe — Argon Medical Devices, Inc.
- Med-Syringe — Argon Medical Devices, Inc.
- Med-Syringe — Argon Medical Devices, Inc.
- Med-Syringe — Argon Medical Devices, Inc.
- Med-Syringe — Argon Medical Devices, 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 |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 246f3c50-2b65-4799-8393-7d233341b8ef 38 fields · synced Jun 9, 2026