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Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm FDA UDI
- Generic Name
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
- Device Name
- Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm FDA UDI
- Model / Reference
- 239-91-238 FDA UDI
- Description
- Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm FDA UDI
Identifiers
- Catalog Number
- IFLX-DFS-6mm FDA UDI
- Primary DI / UDI-DI
- B90823991238 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Intraoperative orthopaedic bone pin/screw, single-use 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraoperative orthopaedic bone pin/screw, single-use
Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm by Mainstream Medical Devices — Class I — FDA UDI — listed in FDA GUDID
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Mainstream Medical Devices
Sources (1)
- FDA UDI 73d0e074-0c09-42eb-ab1f-484ab012ffed 34 fields · synced Jun 1, 2026