Streamline OCT Occipito-Cervico-Thoracic System 26-CC-PB-ROD-75

GUDID 00846468093174

ROD, PRE-BENT

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00846468093174
NIH Device Record Key7524771c-1715-407e-8df4-c04f5137e160
Commercial Distribution StatusIn Commercial Distribution
Brand NameStreamline OCT Occipito-Cervico-Thoracic System
Version Model Number26-CC-PB-ROD-75
Catalog Number26-CC-PB-ROD-75
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100846468093174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior cervical screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


[00846468093174]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

On-Brand Devices [Streamline OCT Occipito-Cervico-Thoracic System]

00846468000011STREAMLINE OCT, RIGID SCREW INSERTER
00846468093211ROD, PRE-BENT
00846468093204ROD, PRE-BENT
00846468093198ROD, PRE-BENT
00846468093181ROD, PRE-BENT
00846468093174ROD, PRE-BENT
00846468093167ROD, PRE-BENT
00846468093150ROD, PRE-BENT
00846468093143ROD, PRE-BENT
00846468093136ROD, PRE-BENT
00846468095635Pre-Bent Rod Case, Empty
00846468058227SCREW, HIGH ANGLE
00846468058203SCREW, HIGH ANGLE
00846468058197SCREW, HIGH ANGLE
00846468058173SCREW, HIGH ANGLE
00846468058166SCREW, HIGH ANGLE
00846468058142SCREW, HIGH ANGLE
00846468058135SCREW, HIGH ANGLE
00846468057800SCREW, HIGH ANGLE
00846468057787SCREW, HIGH ANGLE
00846468057770SCREW, HIGH ANGLE
00846468057756SCREW, HIGH ANGLE
00846468057749SCREW, HIGH ANGLE
00846468057725SCREW, HIGH ANGLE
00846468057718SCREW, HIGH ANGLE
00846468057282HEAD-TO-HEAD CROSSLINK - XXL
00846468057275HEAD-TO-HEAD CROSSLINK - XL
00846468054656ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE
00846468054649ROD-TO-ROD CROSSLINK, EXTRA-LARGE
00846468048501OCCIPITAL SCREW, SPLIT-TIP
00846468048488OCCIPITAL SCREW, SPLIT-TIP
00846468048464OCCIPITAL SCREW, SPLIT-TIP
00846468048433OCCIPITAL SCREW, SPLIT-TIP
00846468048419OCCIPITAL SCREW, SPLIT-TIP
00846468048396OCCIPITAL SCREW, SPLIT-TIP
00846468048372OCCIPITAL SCREW
00846468048358OCCIPITAL SCREW
00846468048327OCCIPITAL SCREW
00846468048303OCCIPITAL SCREW
00846468048280OCCIPITAL SCREW
00846468048266OCCIPITAL SCREW
00846468048242OCCIPITAL SCREW
00846468048211OCCIPITAL SCREW
00846468048198OCCIPITAL SCREW
00846468048174OCCIPITAL SCREW
00846468000349Pre-Bent Rod Case
00846468000332Option Case 2
00846468000325Option Case
00846468000318Occipital Case 2
00846468000301Occipital Case

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