Identity
- Trade Name
- FloSteady FDA UDI
- Generic Name
- Arthroscopic irrigation/insufflation system FDA UDI
- Device Name
- Arthroscopy Pump, Model 150 FDA UDI
- Model / Reference
- 0350800001 FDA UDI
- Description
- Arthroscopy Pump, Model 150 FDA UDI
Identifiers
- Catalog Number
- 0350-800-001 FDA UDI
- Primary DI / UDI-DI
- 07613327057522 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Arthroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arthroscopic irrigation/insufflation system
FloSteady by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic irrigation/insufflation system.
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class II
- FMS VUE II — Medos International Sàrl · Class II
- GoFlo Pump — W.O.M. World of Medicine GmbH · Class II
- SHAVER INTERFACE — Biomet Orthopedics, Inc. · Class I
- Coblation — Smith & Nephew, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- GoFlo Pump — W.O.M. World of Medicine GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 4bcfb83e-44c0-43e5-9b3d-fe3f0c121b3d 35 fields · synced May 30, 2026