Identity
- Trade Name
- Soft Tissue Biopsy Tray FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, medicated FDA UDI
- Device Name
- Soft Tissue Biopsy Tray with Safety Needles & Devices FDA UDI
- Model / Reference
- A4382SP FDA UDI
- Description
- Soft Tissue Biopsy Tray with Safety Needles & Devices FDA UDI
Identifiers
- Catalog Number
- A4382SP FDA UDI
- Primary DI / UDI-DI
- 00886333220779 FDA UDI
- FDA Product Code
- OJT FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soft Tissue Biopsy Tray by Argon Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 3dc49c83-ce7c-42a9-8063-aa067bdde5f8 36 fields · synced Jun 9, 2026