| Primary Device ID | B183FSBMHN1104X0 |
| NIH Device Record Key | 1a10b197-a669-460e-b5e6-ac1e73c0cfe5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Marrow Harvest Needle |
| Version Model Number | FS-BMHN1104X |
| Catalog Number | FS-BMHN1104X |
| Company DUNS | 042993143 |
| Company Name | FLOSPINE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com | |
| Phone | (561)705-3080 |
| info@flospine.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B183FSBMHN1104X0 [Primary] |
| KNW | Instrument, Biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-14 |
| Device Publish Date | 2025-04-04 |
| B1830171000120 - Canaveral® | 2025-04-14 2.4mm Drill |
| B1830172000360 - Canaveral® | 2025-04-14 Guide K-Wire, Nitinol, Blunt Tip, 1.6mm x 500mm |
| B1830172000370 - Canaveral® | 2025-04-14 Guide K-Wire, Stainless Steel, Blunt Tip, 1.6mm x 500mm |
| B183FSBMHN1104X0 - Bone Marrow Harvest Needle | 2025-04-14Bone Marrow Harvest Needle 11ga x 4in |
| B183FSBMHN1104X0 - Bone Marrow Harvest Needle | 2025-04-14 Bone Marrow Harvest Needle 11ga x 4in |
| B183FSDBANJ0806TL0 - Bone Acess Needle | 2025-04-14 Bone Acess Needle 8ga x 6in |
| B183FSDBANJ1106TL0 - Bone Acess Needle | 2025-04-14 Bone Access Needle 11ga x 6in |
| B1830112000010 - Canaveral® | 2025-04-11 Polyaxial Set Screw |
| B1830112450500 - Canaveral® | 2025-04-07 Reduction Polyaxial Screw Assembly, 4.5mm x 50mm |