Primary Device ID | 00859506006135 |
NIH Device Record Key | 3507efcd-f8fa-4d86-848d-ab9745d589ac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Triton Canister System |
Version Model Number | PN 11035 |
Company DUNS | 968757448 |
Company Name | GAUSS SURGICAL, INC |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00859506006135 [Primary] |
PBZ | Image Processing Device For Estimation Of External Blood Loss |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-07-26 |
Device Publish Date | 2018-06-25 |
00859506006135 | MediVac CRD 3L v2 Scanning Label and Insert (PN 11032 and PN 11012) |
00859506006128 | MediVac Guardian 2L Scanning Label and Insert (PN 11032 and PN 11025) |
00859506006104 | Medivac Guardian 3L v2 Scanning Label and Insert (PN 11032 and PN 11001) |
00859506006043 | MediVac CRD 2L Scanning label and Insert (PN 11000 and PN 11025) |
00859506006036 | MediVac CRD 3L Scanning label and Insert (PN 11000 and PN 11012) |
00859506006029 | GAUS-02 |
00859506006012 | PN 11004 |