Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Bone Marrow Biopsy / Aspiration Needle,J-Type FDA UDI
- Model / Reference
- 8881247111 EUDAMEDFDA UDI
- Description
- Bone Marrow Biopsy / Aspiration Needle,J-Type FDA UDI
Identifiers
- Catalog Number
- 8881247111 FDA UDI
- Primary DI / UDI-DI
- 10884521020498 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10884521020498 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A01020299 NEEDLES AND KITS - BONE MARROW BIOPSY - OTHER EUDAMED
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 — 4 Inch FDA UDI
8881247111 by Covidien llc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10884521020498 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Covidien llc
- EUDAMED SRN
- US-MF-000017721
- Authorised Representative
- Covidien Ireland Limited IE-AR-000002274
Sources (3)
- EUDAMED e33c09c6-ae09-4888-9d20-53d530f016f3 61 fields · synced Jul 17, 2026
- FDA UDI 7230a8da-51c0-4d54-ad87-449d2b9b833d 37 fields · synced May 30, 2026
- EUDAMED e45148cd-f040-4226-b0e6-68a67bbdb2f3 61 fields · synced Jul 17, 2026