Streamline® MIS Spinal Fixation System 51-GW-400-SHARP-TH

GUDID 00846468056421

GUIDEWIRE, SHARP TIP, THREADED, SS

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00846468056421
• NIH Device Record Key: 45027a61-cae4-46c1-8626-843f28fafc8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® MIS Spinal Fixation System
• Version Model Number: 51-GW-400-SHARP-TH
• Catalog Number: 51-GW-400-SHARP-TH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468056421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130286

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

[00846468056421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

On-Brand Devices [Streamline® MIS Spinal Fixation System]

• 00846468065966: Rod Caddy Lid Replacement
• 00846468065959: Rod Caddy Lid Replacement
• 00846468065942: Rod Caddy Lid Replacement
• 00846468065935: Rod Caddy Lid Replacement
• 00846468065881: SCREW CADDY
• 00846468064143: INSTRUMENT CASE 2, EMPTY
• 00846468064136: INSTRUMENT CASE 1, EMPTY
• 00846468063139: STRAIGHT LONG ROD CADDY
• 00846468063122: STRAIGHT LARGE ROD CADDY
• 00846468063115: STRAIGHT SMALL ROD CADDY
• 00846468063108: PRE-BENT LONG ROD CADDY
• 00846468061159: LARGE ROD CADDY LID REPLACEMENT
• 00846468061142: SMALL ROD CADDY LID REPLACEMENT
• 00846468061135: SCREW CADDY LID REPLACEMENT
• 00846468060343: SEQUENTIAL DILATOR 4
• 00846468060336: SEQUENTIAL DILATOR 3
• 00846468060329: SEQUENTIAL DILATOR 2
• 00846468060312: SEQUENTIAL DILATOR 1
• 00846468060305: CANNULATED TAP, BLUNT
• 00846468060299: CANNULATED TAP, BLUNT
• 00846468060282: CANNULATED TAP, BLUNT
• 00846468060275: CANNULATED TAP, BLUNT
• 00846468060268: CANNULATED TAP, BLUNT
• 00846468060251: CANNULATED TAP, BLUNT
• 00846468060244: CANNULATED TAP, BLUNT
• 00846468060237: CANNULATED TAP, BLUNT
• 00846468060220: CANNULATED TAP, BLUNT
• 00846468060213: CANNULATED TAP, BLUNT
• 00846468060206: 8.5mm AUXILIARY CASE, EMPTY
• 00846468060190: 4.5mm AUXILIARY CASE, EMPTY
• 00846468060183: GUIDEWIRE, SHARP TIP, SS
• 00846468060176: GUIDEWIRE, SHARP TIP, SS
• 00846468060169: GUIDEWIRE, SHARP TIP, SS
• 00846468060152: GUIDEWIRE, SHARP TIP, SS
• 00846468060145: GUIDEWIRE, SHARP TIP, SS
• 00846468060138: GUIDEWIRE, SHARP TIP, SS
• 00846468060121: GUIDEWIRE, DULL TIP, SS
• 00846468060114: GUIDEWIRE, DULL TIP, SS
• 00846468060107: GUIDEWIRE, DULL TIP, SS
• 00846468060091: GUIDEWIRE, DULL TIP, SS
• 00846468060084: GUIDEWIRE, DULL TIP, SS
• 00846468060077: GUIDEWIRE, DULL TIP, SS
• 00846468060060: GUIDEWIRE, BLUNT TIP, SS
• 00846468060053: GUIDEWIRE, BLUNT TIP, SS
• 00846468060046: GUIDEWIRE, BLUNT TIP, SS
• 00846468060039: GUIDEWIRE, BLUNT TIP, SS
• 00846468060022: GUIDEWIRE, BLUNT TIP, SS
• 00846468060015: GUIDEWIRE, BLUNT TIP, SS
• 00846468060008: IMPLANT CASE, EMPTY
• 00846468056513: GUIDEWIRE, BLUNT TIP, THREADED, SS