← Back to catalogue

OmniBone Bone Biopsy Kit with 11 Gauge 68mm length

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
OmniBone Bone Biopsy Kit with 11 Gauge 68mm length FDA UDI
Generic Name
Bone biopsy needle FDA UDI
Model / Reference
OMB11/6.5 FDA UDI

Identifiers

Primary DI / UDI-DI
00810563022728 FDA UDI
510(k) Number
K230015 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Bone biopsy needle 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
MRI Safety
MR Unsafe FDA UDI

Category: Bone biopsy needle

OmniBone Bone Biopsy Kit with 11 Gauge 68mm length by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone biopsy needle.

Cleared under the same submission

K230015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI 611f0981-fc20-4e8b-9de4-9178ab292fd7 33 fields · synced Jun 8, 2026