Identity
- Trade Name
- Embedding Cassette FDA UDI
- Generic Name
- Tissue embedding mould IVD, single-use FDA UDI
- Device Name
- Biopsy, One Compartment, 1.6 x 1.6 mm, 45°, Lid Attached, Back Hinge, Tan, Bulk FDA UDI
- Model / Reference
- EC0303TXB FDA UDI
- Description
- Biopsy, One Compartment, 1.6 x 1.6 mm, 45°, Lid Attached, Back Hinge, Tan, Bulk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810049681555 FDA UDI
- FDA Product Code
- IDZ FDA UDI
- GMDN Term
- Tissue embedding mould IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tissue embedding mould IVD, single-use
Get the most up-to-date information on the Embedding Cassette, a precision biopsying device used for pathological specimens. Our expert guidance helps you navigate the complexities of this innovative product, providing detailed answers to your frequently asked questions.
Similar devices
Also classified as Tissue embedding mould IVD, single-use.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Tissue-Tek® Cryomold® — Sakura Finetek USA, Inc · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Typenex Medical, LLC
Sources (1)
- FDA UDI 29bf8ac2-f5c6-40e2-9256-f89bf40a5a33 33 fields · synced Jun 28, 2026