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iFuse Implant System-Length Gage TiN Coating
FDA UDIClass I (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- iFuse Implant System-Length Gage TiN Coating FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Length Gage TiN Coating FDA UDI
- Model / Reference
- 500655N FDA UDI
- Description
- Length Gage TiN Coating FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851085007435 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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
No
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
MR Conditional FDA UDI
Category: Surgical depth gauge, reusable
iFuse Implant System-Length Gage TiN Coating by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
- Depth Gauge — I.T.S. GmbH · Class I
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- FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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
- Si-Bone Inc.
Sources (1)
- FDA UDI 86443b33-9fdb-4f4d-b421-e7f8dc459362 34 fields · synced Jun 8, 2026