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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
- Absorbent underpad, antimicrobial FDA UDI
- Device Name
- Anti Microbial pads FDA UDI
- Model / Reference
- P45-600-1000-S FDA UDI
- Description
- Anti Microbial pads FDA UDI
Identifiers
- Catalog Number
- P45-600-1000-S FDA UDI
- Primary DI / UDI-DI
- 00889795118004 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Absorbent underpad, antimicrobial 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
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
Yes
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: Absorbent underpad, antimicrobial
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 Absorbent underpad, antimicrobial.
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- DriPad — Merit Medical Systems, Inc. · Class I
- DriPad — Merit Medical Systems, Inc. · Class I
- DriPad — Merit Medical Systems, Inc. · Class I
- DriPad — Merit Medical Systems, Inc. · Class I
- COMFORT TOUCH — Slv Pharmaceuticals LLC · 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 c65920b2-f6af-4100-ae85-28fb6769c696 34 fields · synced Jun 8, 2026