Identity
- Trade Name
- MReye FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- MReye, Disposable Chiba Biopsy Needle Inconel FDA UDI
- Model / Reference
- G11583 FDA UDI
- Description
- MReye, Disposable Chiba Biopsy Needle Inconel FDA UDI
Identifiers
- Catalog Number
- IDCHN-20-10.0 FDA UDI
- Primary DI / UDI-DI
- 00827002115835 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Body aspiration needle, single-use
MReye by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FNA WESTCOTT — Medax Unipersonale Srl · Class II
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
- Cook Incorporated
Sources (1)
- FDA UDI c8597afb-5327-4807-b261-ee6ca8d36464 36 fields · synced Jun 8, 2026