Identity
- Trade Name
- Disposable Base Mold FDA UDI
- Generic Name
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
- Device Name
- Disposable Base Mold, 17x17x5 FDA UDI
- Model / Reference
- CM0212 FDA UDI
- Description
- Disposable Base Mold, 17x17x5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812269039963 FDA UDI
- FDA Product Code
- IDZ FDA UDI
- GMDN Term
- Histology tissue cassette IVD, laboratory processing, 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: Histology tissue cassette IVD, laboratory processing, single-use
Disposable Base Mold by Typenex Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Histology tissue cassette IVD, laboratory processing, single-use.
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- Tissue-Tek® Paraform® — Sakura Finetek USA, Inc · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Tissue-Tek® Paraform® — Sakura Finetek USA, Inc · 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 |
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Manufacturer
- Manufacturer
- Typenex Medical, LLC
Sources (1)
- FDA UDI e4ca4b7e-c279-408d-b097-1f1a553fa681 33 fields · synced Jun 1, 2026