Identity
- Trade Name
- Introducer Sheath/Needle FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Introducer Sheath/Needle FDA UDI
- Model / Reference
- 19 ga x 20 cm FDA UDI
- Description
- Introducer Sheath/Needle FDA UDI
Identifiers
- Catalog Number
- ISN 1920 FDA UDI
- Primary DI / UDI-DI
- 00886333001668 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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: Needle guide, single-use
Introducer Sheath/Needle by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI 93111d78-cb92-4214-9738-cd0aa997e4a2 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026