Identity
- Trade Name
- GENESYS / PACK TIP [ML] FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Warmed Gutta Percha Obturation System FDA UDI
- Model / Reference
- 9047 FDA UDI
- Description
- Warmed Gutta Percha Obturation System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387890478 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Genesys / Pack Tip [ml] by Meta Biomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Meta Biomed, Inc.
Sources (1)
- FDA UDI 8e934a3a-49da-4d47-a2b7-cb095d7114ac 34 fields · synced May 30, 2026