Identity
- Trade Name
- MED-I FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Bone Marrow Aspiration System 15G x 9 cm FDA UDI
- Model / Reference
- XI15090-01 FDA UDI
- Description
- Bone Marrow Aspiration System 15G x 9 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052283956088 FDA UDI
- 510(k) Number
- K192099 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow biopsy 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 Unsafe FDA UDI
Category: Bone marrow biopsy needle, single-use
Med-I by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
- BMN J TYPE — H.S. HOSPITAL SERVICE SPA · Class II
- 0BIE1410/075 — Biomedical S.r.l. · Class IIa
Cleared under the same submission
K192099 also covers:
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-B — Medax Unipersonale Srl
- MED-I — Medax Unipersonale Srl
- MED-I — Medax Unipersonale Srl
- MED-I — Medax Unipersonale Srl
- MED-I — Medax Unipersonale Srl
- MED-I — Medax Unipersonale Srl
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
- Medax Unipersonale Srl
Sources (1)
- FDA UDI dbf03d0c-7d86-4420-a8f7-6df516e94170 34 fields · synced May 30, 2026