Identity
- Trade Name
- GLUTH ALTO TOTAL FDA UDI
- Generic Name
- Ossicular prosthesis, total FDA UDI
- Device Name
- GLUTH ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE FDA UDI
- Model / Reference
- 648 FDA UDI
- Description
- GLUTH ALTO TOTAL SIZERS INCLUDED TITANIUM/SILICONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505010887 FDA UDI
- 510(k) Number
- K061853 FDA UDI
- FDA Product Code
- ETA FDA UDI
- GMDN Term
- Ossicular prosthesis, total FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3495 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gluth Alto Total by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K061853 also covers:
- ALTO TOTAL — Grace Medical, Inc.
- CENTERED ALTO TOTAL — Grace Medical, Inc.
- DB TITANIUM STRUT — Grace Medical, Inc.
- DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH — Grace Medical, Inc.
- FRISBEE PARTIAL — Grace Medical, Inc.
- FRISBEE PARTIAL — Grace Medical, Inc.
- HA ALTO TOTAL — Grace Medical, Inc.
- HABERMAN ALTO PARTIAL RECTANGLE HEAD — Grace Medical, Inc.
- HABERMAN ALTO TOTAL ROUND HEAD — Grace Medical, Inc.
- MIAMI IS COUPLER PARTIAL – LONG — Grace Medical, Inc.
- MIAMI IS COUPLER PARTIAL – SHORT — Grace Medical, Inc.
- OWENS ASSURE — Grace Medical, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Grace Medical, Inc.
Sources (1)
- FDA UDI 28501513-7d1d-4e89-8b0f-31d77e636087 36 fields · synced Jun 1, 2026