Identity
- Trade Name
- ACHIEVE FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- ADJUSTABLE COAXIAL ACHIEVE NEEDLE BIOPSY 16G X 15CM FDA UDI
- Model / Reference
- ACA1615 FDA UDI
- Description
- ADJUSTABLE COAXIAL ACHIEVE NEEDLE BIOPSY 16G X 15CM FDA UDI
Identifiers
- Catalog Number
- ACA1615 FDA UDI
- Primary DI / UDI-DI
- 10885403222436 FDA UDI
- FDA Product Code
- KNW FDA UDIGDF FDA UDI
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI878.4800 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
- Needle Gauge — 16 Gauge FDA UDILength — 15 Centimeter FDA UDI
Achieve by Carefusion 2200, Inc. — 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
- Carefusion 2200, Inc.
Sources (1)
- FDA UDI fc950305-b67d-4f96-bc17-c9a59748f7a5 37 fields · synced Sep 18, 2026