| Primary Device ID | 00840185307316 |
| NIH Device Record Key | 8f1fbe27-e9d2-43be-abe9-6de07358b4d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4CIS SARA/VERTU SPINE SYSTEM |
| Version Model Number | AISP-1507-5515 |
| Catalog Number | 1507-5515 |
| Company DUNS | 868354728 |
| Company Name | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | 00840185307316 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
[00840185307316]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2021-03-30 |
| 00840185308177 | Cross Link Size- 50-70 mm |
| 00840185308160 | Cross Link Size- 40-53 mm |
| 00840185308153 | Cross Link Size-38-46 mm |
| 00840185308146 | Cross Link Size-34-32 mm |
| 00840185308139 | Cross Link Size-30-34 mm |
| 00840185311283 | Rod: Ø 5.5 mm, Length 200 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311276 | Rod: Ø 5.5 mm, Length 190 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311269 | Rod: Ø 5.5 mm, Length 180 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311252 | Rod: Ø 5.5 mm, Length 170 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311245 | Rod: Ø 5.5 mm, Length 160 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311238 | Rod: Ø 5.5 mm, Length 150 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311221 | Rod: Ø 5.5 mm, Length 140 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311214 | Rod: Ø 5.5 mm, Length 130 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311207 | Rod: Ø 5.5 mm, Length 120 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311191 | Rod: Ø 5.5 mm, Length 110 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311184 | Rod: Ø 5.5 mm, Length 100 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185311177 | Rod: Ø 5.5 mm, Length 90 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185311160 | Rod: Ø 5.5 mm, Length 80 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185311153 | Rod: Ø 5.5 mm, Length 70 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185311146 | Rod: Ø 5.5 mm, Length 60 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185311139 | Rod: Ø 5.5 mm, Length 50 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185311122 | Rod: Ø 5.5 mm, Length 40 mm , Pre-Bent, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F |
| 00840185307811 | Rod: Ø 5.5 mm, Length 500 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185307804 | Rod: Ø 5.5 mm, Length 450 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185307798 | Rod: Ø 5.5 mm, Length 400 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185307781 | Ø 5.5 mm, Length 350 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136 |
| 00840185307774 | Rod: Ø 5.5 mm, Length 300 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185307767 | Rod: Ø 5.5 mm, Length 290 mm , Hex end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM |
| 00840185307750 | Rod: Ø 5.5 mm, Length 280 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307743 | Rod: Ø 5.5 mm, Length 270 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307736 | Rod: Ø 5.5 mm, Length 260 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307729 | Rod: Ø 5.5 mm, Length 250 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307712 | Rod: Ø 5.5 mm, Length 240 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307705 | Rod: Ø 5.5 mm, Length 230 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307699 | Rod: Ø 5.5 mm, Length 220 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307682 | Rod: Ø 5.5 mm, Length 210 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307675 | Rod: Ø 5.5 mm, Length 200 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307668 | Rod: Ø 5.5 mm, Length 190 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307651 | Rod: Ø 5.5 mm, Length 180 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307644 | Rod: Ø 5.5 mm, Length 170 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307637 | Rod: Ø 5.5 mm, Length 160 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307620 | Rod: Ø 5.5 mm, Length 150 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307613 | Rod: Ø 5.5 mm, Length 140 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307606 | Rod: Ø 5.5 mm, Length 130 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307590 | Rod: Ø 5.5 mm, Length 120 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307583 | Rod: Ø 5.5 mm, Length 110 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307576 | Rod: Ø 5.5 mm, Length 100 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F1 |
| 00840185307569 | Rod: Ø 5.5 mm, Length 90 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F13 |
| 00840185307552 | Rod: Ø 5.5 mm, Length 80 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F13 |
| 00840185307545 | Rod: Ø 5.5 mm, Length 70 mm , Hex end Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F13 |