Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Printer label IVD FDA UDI
- Device Name
- RDA-Tag Label Kit FDA UDI
- Model / Reference
- 8637-K001 FDA UDI
- Description
- RDA-Tag Label Kit FDA UDI
Identifiers
- Catalog Number
- 8637-K001 FDA UDI
- Primary DI / UDI-DI
- 00615233002440 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Printer label IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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
Category: Printer label IVD
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Tissue-Tek Genie® — 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 31847df6-57a6-4ac4-8088-eef382661c6b 35 fields · synced May 30, 2026