Identity
- Trade Name
- Busse Hospital Disposables FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- I-Style Bone Marrow Aspiration Needle with T-Handle, 15G adjustable from 5/8" - 1" FDA UDI
- Model / Reference
- 632 FDA UDI
- Description
- I-Style Bone Marrow Aspiration Needle with T-Handle, 15G adjustable from 5/8" - 1" FDA UDI
Identifiers
- Catalog Number
- 632 FDA UDI
- Primary DI / UDI-DI
- 00849233001619 FDA UDI
- 510(k) Number
- K120002 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
No
FDA UDI
Category: Bone marrow biopsy needle, single-use
Busse Hospital Disposables by Robert Busse & Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Robert Busse & Co., Inc.
Sources (1)
- FDA UDI d1d07157-2ae7-437f-be4d-6d5be5b2fc9e 36 fields · synced May 30, 2026