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masterguard plus HEMODIALYSIS FISTULA NEEDLE SET
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- masterguard plus HEMODIALYSIS FISTULA NEEDLE SET FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Device Name
- SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGPLB FDA UDI
- Model / Reference
- D9-7006MGPLB FDA UDI
- Description
- SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGPLB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842289102415 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
- 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
- Needle Gauge — 16 Gauge FDA UDILength — 1 Inch FDA UDI
Category: Haemodialysis needle
masterguard plus HEMODIALYSIS FISTULA NEEDLE SET by NxStage Medical, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Haemodialysis needle.
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- Nipro SafeTouch TULIP Safety Fistula Needle — NIPRO MEDICAL CORPORATION · Class II
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE — NIPRO MEDICAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NxStage Medical, Inc.
Sources (2)
- FDA UDI aee60d39-b531-4624-a6f2-7222573d44e4 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026