Identity
- Trade Name
- Introducer Sheath/Needle FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Introducer Sheath/Needle 19ga x 15cm FDA UDI
- Model / Reference
- ISN1915 FDA UDI
- Description
- Introducer Sheath/Needle 19ga x 15cm FDA UDI
Identifiers
- Catalog Number
- ISN1915 FDA UDI
- Primary DI / UDI-DI
- 00886333224388 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
Yes
FDA UDI
Category: Needle guide, single-use
Introducer Sheath/Needle by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 ad4550e6-c26d-49ef-b90b-b309666298ab 36 fields · synced Jun 9, 2026