Primary Device ID | 00850034511399 |
NIH Device Record Key | e4cea344-450b-4d5a-89e8-e9ffb5157c61 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Puregraft Serene Breast Implant |
Version Model Number | 300CC |
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 | false |
Serial Number | true |
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 |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Total Volume | 300 Milliliter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850034511368 [Primary] |
GS1 | 00850034511399 [Package] Contains: 00850034511368 Package: Box [1 Units] In Commercial Distribution |
FWM | Prosthesis, Breast, Inflatable, Internal, Saline |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-05 |
Device Publish Date | 2024-03-28 |
00850034511931 | Saline Breast Implant |
00850034511924 | Saline Breast Implant |
00850034511894 | Saline Breast Implant |
00850034511863 | Saline Breast Implant |
00850034511825 | Saline Breast Implant |
00850034511801 | Saline Breast Implant |
00850034511771 | Saline Breast Implant |
00850034511757 | Saline Breast Implant |
00850034511672 | Saline Breast Implant |
00850034511658 | Saline Breast Implant |
00850034511627 | Saline Breast Implant |
00850034511399 | Saline Breast Implant |
00850034511337 | Saline Breast Implant |
00850034511153 | Saline Breast Implant |