Primary Device ID | 10850034511310 |
NIH Device Record Key | 3bd2a85d-75ab-478d-9449-3a3dccdba03d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Healeon HD PRP |
Version Model Number | HDPRP15 |
Company DUNS | 076649467 |
Company Name | Bimini Technologies 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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850034511313 [Primary] |
GS1 | 10850034511310 [Package] Contains: 00850034511313 Package: Box [3 Units] In Commercial Distribution |
ORG | Platelet And Plasma Separator For Bone Graft Handling |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-25 |
Device Publish Date | 2022-02-17 |
00850034511405 | A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo |
10850034511310 | A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended fo |