Identity
- Trade Name
- STOMA® FDA UDI
- Generic Name
- Periotome, reusable FDA UDI
- Device Name
- Hammerhead Periotome Elaskary, DE, Ø10mm FDA UDI
- Model / Reference
- 12969.10 FDA UDI
- Description
- Hammerhead Periotome Elaskary, DE, Ø10mm FDA UDI
Identifiers
- Catalog Number
- 12969.10 FDA UDI
- Primary DI / UDI-DI
- ESAM12969101 FDA UDI
- FDA Product Code
- EMO FDA UDI
- GMDN Term
- Periotome, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Periotome, reusable
Stoma® by Storz am Mark GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Storz am Mark GmbH
Sources (1)
- FDA UDI 4ea3d15b-4b49-4b14-9d75-1b1b7cd2871c 35 fields · synced Jun 8, 2026