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OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Model / Reference
- OMM 11/15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810563023039 FDA UDI
- 510(k) Number
- K230015 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
No
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
OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm by Varian Medical Systems, Inc — 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
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
Cleared under the same submission
K230015 also covers:
- OmniBone Bone Biopsy Kit with 11 Gauge 108mm length — Varian Medical Systems, Inc
- OmniBone Bone Biopsy Kit with 11 Gauge 158mm length — Varian Medical Systems, Inc
- OmniBone Bone Biopsy Kit with 11 Gauge 68mm length — Varian Medical Systems, Inc
- OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm — Varian Medical Systems, Inc
- OmniBone Charger — Varian Medical Systems, Inc
- OmniBone Power Driver — Varian Medical Systems, Inc
- OmniBone Power Driver and Charger — Varian Medical Systems, Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI 537b1a79-6cdb-4d5a-970c-2b10247ac86d 33 fields · synced May 30, 2026