Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, medicated FDA UDI
- Device Name
- BREAST BIOPSY TRAY FDA UDI
- Model / Reference
- DYNDH1680 FDA UDI
- Description
- BREAST BIOPSY TRAY FDA UDI
Identifiers
- Catalog Number
- DYNDH1680 FDA UDI
- Primary DI / UDI-DI
- 10653160348894 FDA UDI
- FDA Product Code
- PXP 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
- 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 Breast Biopsy Tray is a sterile, single-use device designed for the collection of soft tissue biopsies. With its compact design and convenient handling, it is ideal for general plastic surgery procedures.
Similar devices
Also classified as Soft-tissue biopsy procedure kit, medicated.
- Centurion — Centurion Medical Products · Class I
- General Biopsy Tray — Argon Medical Devices, Inc. · Class I
- General Biopsy Tray — Argon Medical Devices, Inc. · Class I
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 0c02a1db-6384-40be-aca8-123f4b12df58 35 fields · synced Jul 9, 2026