FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm
DI: 00810563022827
·
Model: OMM 11/10
·
Varian Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm
- Primary DI
- 00810563022827
- Version / Model
- OMM 11/10
- Company Name
- Varian Medical Systems, Inc.
- Labeler DUNS
- 118097024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-18
- Public Version
- 2
- Public Version Date
- 2025-10-06
- Public Version Status
- Update
- Public Device Record Key
- 3caea7df-634c-419d-b207-63861f40b577
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | Instrument, biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46350 | Bone marrow biopsy needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810563022824 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00810563022827 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230015 | 000 |