Identity
- Trade Name
- ButtonHole with SteriPick TWINPACK+ NEEDLE SET FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Device Name
- TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2007PE FDA UDI
- Model / Reference
- BH-2007PE FDA UDI
- Description
- TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK INCLUDED WITH TWINPACK BH-2007PE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842289102019 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 — 17 Gauge FDA UDILength — 1 Inch FDA UDI
Category: Haemodialysis needle
ButtonHole with SteriPick TWINPACK+ NEEDLE SET by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis needle.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- NxStage Medical, Inc.
Sources (1)
- FDA UDI e2ae4e36-7db7-4f55-922a-e701c370af5f 36 fields · synced Jun 9, 2026