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Paratrooper™ Plantar Plate Repair System
FDA UDIClass II (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Paratrooper™ Plantar Plate Repair System FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Paratrooper Plantar Plate Repair System, Implant Only Kit- Sterile FDA UDI
- Model / Reference
- P13-000-5016-S FDA UDI
- Description
- Paratrooper Plantar Plate Repair System, Implant Only Kit- Sterile FDA UDI
Identifiers
- Catalog Number
- P13-000-5016-S FDA UDI
- Primary DI / UDI-DI
- 00889795118479 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Suturing unit, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Suturing unit, single-use
Paratrooper™ Plantar Plate Repair System by Paragon 28 — 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
- Paragon 28
Sources (1)
- FDA UDI 566007b4-9c63-4e1f-aab3-9fe137c2a2e4 34 fields · synced May 30, 2026