Identity
- Trade Name
- Monster Screw System FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Cannulated Cleaning Stylet, 2.3mm FDA UDI
- Model / Reference
- P99-998-0023 FDA UDI
- Description
- Cannulated Cleaning Stylet, 2.3mm FDA UDI
Identifiers
- Catalog Number
- P99-998-0023 FDA UDI
- Primary DI / UDI-DI
- 00889795041654 FDA UDI
- FDA Product Code
- GAH FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, reusable
Monster Screw System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, reusable.
- LEOS Cannulated Screw System — Tyber Medical · Class I
- MIDAS REX — Medtronic Powered Surgical Solutions · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- 80000 Series Reusable General and Rigid Cleaning Brush — Primed Instruments Inc · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- SafeClean ® General Purpose Brush — Aspen Surgical Products, Inc. · Class I
- 80000 Series Reusable General and Rigid Cleaning Brush — Primed Instruments Inc · Class I
- Patterson® — PATTERSON DENTAL SUPPLY, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 357f8162-509e-4555-b4a1-dc1c5b7cef41 34 fields · synced May 31, 2026