Identity
- Trade Name
- Tatum Tunnel Grafting Kit FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- Tatum Tunnel Grafting Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 12 Instruments. Nine Molt/Periosteal instrument ( 3 Straight, 3 Left hand and 3 Right hand) and Three retractors to reflect tissue once released. FDA UDI
- Model / Reference
- Tunnel Grafting Kit FDA UDI
- Description
- Tatum Tunnel Grafting Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 12 Instruments. Nine Molt/Periosteal instrument ( 3 Straight, 3 Left hand and 3 Right hand) and Three retractors to reflect tissue once released. FDA UDI
Identifiers
- Catalog Number
- Tunnel Grafting Kit FDA UDI
- Primary DI / UDI-DI
- 00083208007774 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Vascular graft tunneller 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tatum Tunnel Grafting Kit by Suncoast Dental, 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
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI d5efbf16-b617-4acd-8761-2e885182442e 36 fields · synced Jun 1, 2026