Primary Device ID | 00850034511207 |
NIH Device Record Key | b8b3a05a-bd3b-4fa9-a7d1-513f4a471744 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Puregraft 850 System |
Version Model Number | 850/PURE |
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 | 00850034511191 [Primary] |
GS1 | 00850034511207 [Package] Contains: 00850034511191 Package: Box [1 Units] In Commercial Distribution |
MUU | System, Suction, Lipoplasty |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-11 |
Device Publish Date | 2022-04-01 |
00850034511993 - DIRECT2 Lid | 2024-10-14 This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an |
00850034511009 - Puregraft 850 System Twin Pack | 2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri |
00850034511153 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |
00850034511337 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |
00850034511399 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |
00850034511627 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |
00850034511658 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |
00850034511672 - Puregraft Serene Breast Implant | 2024-04-05 Saline Breast Implant |