| Primary Device ID | M682113010200 |
| NIH Device Record Key | 210eb106-600a-40d3-b820-b3a8bf5bef87 |
| Commercial Distribution Discontinuation | 2020-09-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ENDOSKELETON Sterile Barrier System |
| Version Model Number | 1130-1020 |
| Catalog Number | 1130-1020 |
| Company DUNS | 623316978 |
| Company Name | TITAN SPINE, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Size Text, specify | 0 |
| Height | 6.5 Inch |
| Width | 13.5 Inch |
| Length | 23 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M682113010200 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
[M682113010200]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2016-09-17 |
| M682113010300 | Caddy, Small |
| M682113010200 | Caddy, Medium |
| M682113010100 | Caddy, Large |