Identity
- Trade Name
- RELI FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- MIELO-CAN® Bone marrow biopsy needle, 15G, 0.86" - 1.57" max 2.36" FDA UDI
- Model / Reference
- R-MCN22 FDA UDI
- Description
- MIELO-CAN® Bone marrow biopsy needle, 15G, 0.86" - 1.57" max 2.36" FDA UDI
Identifiers
- Catalog Number
- R-MCN22 FDA UDI
- Primary DI / UDI-DI
- 00386120008110 FDA UDI
- 510(k) Number
- K051506 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- GMDN Term
- Bone marrow biopsy procedure kit 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
Dimensions & Sizes
- Size
- Needle Gauge — 15 Gauge FDA UDI
Category: Bone marrow biopsy procedure kit
Reli by Myco Medical Supplies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy procedure kit.
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- DBBN-11-15.0-M1M-JP — IZI MEDICAL PRODUCTS LLC · Class II
- TEMNO Evolution® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K051506 also covers:
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
- Myco Medical Supplies Inc.
Sources (1)
- FDA UDI f1b08edc-1968-48dd-95b9-fe874ee6b6c6 36 fields · synced May 30, 2026