ENDOSKELETON® Sterile Barrier System 1130-1030
GUDID 00191375011958
Caddy, Small
TITAN SPINE, LLC
Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| Primary Device ID | 00191375011958 |
| NIH Device Record Key | 59e8b9ff-cacd-4b23-bb5a-aef5029be367 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® Sterile Barrier System |
| Version Model Number | 1130-1030 |
| Catalog Number | 1130-1030 |
| Company DUNS | 623316978 |
| Company Name | TITAN SPINE, LLC |
| 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 | 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
| Width | 13.5 Inch |
| Height | 6.5 Inch |
| Length | 15 Inch |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375011958 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142589
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
[00191375011958]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® Sterile Barrier System]
| 00191375028284 | Soft Caddy, Medium |
| 00191375011972 | Caddy, Large |
| 00191375011965 | Caddy, Medium |
| 00191375011958 | Caddy, Small |
Trademark Results [ENDOSKELETON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSKELETON 76550301 3174488 Live/Registered |
TITAN SPINE, INC. 2003-09-22 |
 ENDOSKELETON 74130100 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1991-01-14 |
 ENDOSKELETON 74130099 1719530 Live/Registered |
STUDIOCANAL, S.A. 1991-01-14 |
 ENDOSKELETON 74124953 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
 ENDOSKELETON 74124952 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.