| Primary Device ID | 00846468093181 |
| NIH Device Record Key | 6be075b0-6b04-44e3-a1a7-0c0685f57d14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Streamline OCT Occipito-Cervico-Thoracic System |
| Version Model Number | 26-CC-PB-ROD-85 |
| Catalog Number | 26-CC-PB-ROD-85 |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 | false |
| 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 |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468093181 [Primary] |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
[00846468093181]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-12-16 |
| 00846468000011 | STREAMLINE OCT, RIGID SCREW INSERTER |
| 00846468093211 | ROD, PRE-BENT |
| 00846468093204 | ROD, PRE-BENT |
| 00846468093198 | ROD, PRE-BENT |
| 00846468093181 | ROD, PRE-BENT |
| 00846468093174 | ROD, PRE-BENT |
| 00846468093167 | ROD, PRE-BENT |
| 00846468093150 | ROD, PRE-BENT |
| 00846468093143 | ROD, PRE-BENT |
| 00846468093136 | ROD, PRE-BENT |
| 00846468095635 | Pre-Bent Rod Case, Empty |
| 00846468058227 | SCREW, HIGH ANGLE |
| 00846468058203 | SCREW, HIGH ANGLE |
| 00846468058197 | SCREW, HIGH ANGLE |
| 00846468058173 | SCREW, HIGH ANGLE |
| 00846468058166 | SCREW, HIGH ANGLE |
| 00846468058142 | SCREW, HIGH ANGLE |
| 00846468058135 | SCREW, HIGH ANGLE |
| 00846468057800 | SCREW, HIGH ANGLE |
| 00846468057787 | SCREW, HIGH ANGLE |
| 00846468057770 | SCREW, HIGH ANGLE |
| 00846468057756 | SCREW, HIGH ANGLE |
| 00846468057749 | SCREW, HIGH ANGLE |
| 00846468057725 | SCREW, HIGH ANGLE |
| 00846468057718 | SCREW, HIGH ANGLE |
| 00846468057282 | HEAD-TO-HEAD CROSSLINK - XXL |
| 00846468057275 | HEAD-TO-HEAD CROSSLINK - XL |
| 00846468054656 | ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE |
| 00846468054649 | ROD-TO-ROD CROSSLINK, EXTRA-LARGE |
| 00846468048501 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048488 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048464 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048433 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048419 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048396 | OCCIPITAL SCREW, SPLIT-TIP |
| 00846468048372 | OCCIPITAL SCREW |
| 00846468048358 | OCCIPITAL SCREW |
| 00846468048327 | OCCIPITAL SCREW |
| 00846468048303 | OCCIPITAL SCREW |
| 00846468048280 | OCCIPITAL SCREW |
| 00846468048266 | OCCIPITAL SCREW |
| 00846468048242 | OCCIPITAL SCREW |
| 00846468048211 | OCCIPITAL SCREW |
| 00846468048198 | OCCIPITAL SCREW |
| 00846468048174 | OCCIPITAL SCREW |
| 00846468000349 | Pre-Bent Rod Case |
| 00846468000332 | Option Case 2 |
| 00846468000325 | Option Case |
| 00846468000318 | Occipital Case 2 |
| 00846468000301 | Occipital Case |