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Medisystems Hemodialysis Fistula Needle Set with MasterGuard
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Medisystems Hemodialysis Fistula Needle Set with MasterGuard FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Device Name
- MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2016MG FDA UDI
- Model / Reference
- D9-7016MG FDA UDI
- Description
- MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2016MG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842289100459 FDA UDI
- FDA Product Code
- FIE FDA UDI
- GMDN Term
- Haemodialysis needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.25 Inch FDA UDINeedle Gauge — 16 Gauge FDA UDI
Medisystems Hemodialysis Fistula Needle Set with MasterGuard by Medisystems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Medisystems Corp.
Sources (1)
- FDA UDI 9ff66ff7-f23b-4255-afbe-9f23ed6e8280 37 fields · synced Jun 6, 2026