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Monkey Rings™ External Fixation System
FDA UDIClass I (US FDA UDI)
by Paragon 28
Identity
- Trade Name
- Monkey Rings™ External Fixation System FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- Universal Pin Clamp FDA UDI
- Model / Reference
- P45-970-2000 FDA UDI
- Description
- Universal Pin Clamp FDA UDI
Identifiers
- Catalog Number
- P45-970-2000 FDA UDI
- Primary DI / UDI-DI
- 00889795116208 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone approximation clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone approximation clamp
Monkey Rings™ External Fixation System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone approximation clamp.
- Journey II — Smith & Nephew, Inc. · Class II
- PERI-LOC VLP — Smith & Nephew, Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class I
- Bone Clamp — Koros USA, Inc. · Class I
- PROFIX — Smith & Nephew, Inc. · Class II
- Sklar® — Sklar Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Symmetry Martin — SYMMETRY SURGICAL INC. · 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
- Paragon 28
Sources (1)
- FDA UDI 6d22d412-54f9-4bc7-b56c-e08fad8fe04f 34 fields · synced May 30, 2026