Identity
- Trade Name
- PONTiS Flexor Tendon Repar System FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile. FDA UDI
- Model / Reference
- 400-3015 FDA UDI
- Description
- PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile. FDA UDI
Identifiers
- Catalog Number
- 400-3015 FDA UDI
- Primary DI / UDI-DI
- 00859210006049 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Dimensions & Sizes
- Size
- Length — 4 Inch FDA UDIOuter Diameter — 0.094 Inch FDA UDIOuter Diameter — 0.078 Inch FDA UDIOuter Diameter — 0.063 Inch FDA UDI
Category: Orthopaedic trocar blade, reusable
PONTiS Flexor Tendon Repar System by Pontis Orthopaedics, LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pontis Orthopaedics, LLC
Sources (1)
- FDA UDI 337590e8-ff06-454b-a312-0f3290baaad9 36 fields · synced May 31, 2026