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Medisystems TwinPack ButtonHole Needle Set with SteriPick
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Medisystems TwinPack ButtonHole Needle Set with SteriPick FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Device Name
- MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES) FDA UDI
- Model / Reference
- BH-2006PE FDA UDI
- Description
- MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 1" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842289100084 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 Inch FDA UDINeedle Gauge — 16 Gauge FDA UDI
Medisystems TwinPack ButtonHole Needle Set with SteriPick 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 ef637d96-c474-45e9-ab01-1e6655092a90 37 fields · synced Jun 1, 2026