Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, medicated FDA UDI
- Device Name
- CT BIOPSY TRAY FDA UDI
- Model / Reference
- DYNDH1580 FDA UDI
- Description
- CT BIOPSY TRAY FDA UDI
Identifiers
- Catalog Number
- DYNDH1580 FDA UDI
- Primary DI / UDI-DI
- 10193489198768 FDA UDI
- FDA Product Code
- OFG FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
No
FDA UDI
Category: Soft-tissue biopsy procedure kit, medicated
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy procedure kit, medicated.
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- Centurion — Centurion Medical Products · Class I
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- CUSTOM HEALTHCARE SYSTEMS, INC — Manus Medical, LLC · Class II
- MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC. · Class II
- Custom Healthcare Systems, Inc. — Manus Medical, LLC · 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 1cee382c-6ece-4551-b8fc-8c2621085fe9 35 fields · synced May 31, 2026