BULLET-TIP PEEK IBF SYSTEM 30-P-INSERTER-CL

GUDID 00846468086664

INSERTER MODULAR CLEANING

Pioneer Surgical Technology, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00846468086664
• NIH Device Record Key: ee635216-4d0c-4733-aa48-25d173a189de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET-TIP PEEK IBF SYSTEM
• Version Model Number: 30-P-INSERTER-CL
• Catalog Number: 30-P-INSERTER-CL
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• 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: 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

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: 386-418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468035501 [Primary]
GS1	00846468086664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150521

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

[00846468086664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-30
• Device Publish Date: 2019-12-21

On-Brand Devices [BULLET-TIP PEEK IBF SYSTEM]

• 00846468086664: INSERTER MODULAR CLEANING
• 00846468077945: INSTRUMENT CASE
• 00846468074746: INSTRUMENT CASE
• 00846468066789: SHORT, INLINE HANDLE, HUDSON
• 00846468066772: 32mm, TRIAL CADDY
• 00846468066765: 26mm, TRIAL CADDY
• 00846468066758: 22mm, TRIAL CADDY
• 00846468066543: 26MM, Lordotic Detachable Trial Caddy
• 00846468066536: 22mm, Lordotic Detachable Trial Caddy
• 00846468066161: TRIAL SPACER
• 00846468066154: TRIAL SPACER
• 00846468066147: TRIAL SPACER
• 00846468066130: TRIAL SPACER
• 00846468066116: TRIAL SPACER
• 00846468066109: TRIAL SPACER
• 00846468066093: TRIAL SPACER
• 00846468066086: TRIAL SPACER
• 00846468066079: TRIAL SPACER
• 00846468066062: TRIAL SPACER
• 00846468066055: TRIAL SPACER
• 00846468066048: TRIAL SPACER
• 00846468066031: TRIAL SPACER
• 00846468066024: TRIAL SPACER
• 00846468066017: TRIAL SPACER
• 00846468066000: TRIAL SPACER
• 00846468065997: TRIAL SPACER
• 00846468065980: TRIAL SPACER
• 00846468065973: TRIAL SPACER
• 00846468054557: INSERTER
• 00846468054540: DETACHABLE TRIAL SPACER
• 00846468054533: DETACHABLE TRIAL SPACER
• 00846468054526: DETACHABLE TRIAL SPACER
• 00846468054519: DETACHABLE TRIAL SPACER
• 00846468054502: DETACHABLE TRIAL SPACER
• 00846468054496: DETACHABLE TRIAL SPACER
• 00846468054489: DETACHABLE TRIAL SPACER
• 00846468054472: DETACHABLE TRIAL SPACER
• 00846468054465: DETACHABLE TRIAL SPACER
• 00846468054458: DETACHABLE TRIAL SPACER
• 00846468054441: DETACHABLE TRIAL SPACER
• 00846468054434: DETACHABLE TRIAL SPACER
• 00846468054427: DETACHABLE TRIAL SPACER
• 00846468054410: DETACHABLE TRIAL SPACER
• 00846468054403: DETACHABLE TRIAL SPACER
• 00846468054397: DETACHABLE TRIAL SPACER
• 00846468054380: DETACHABLE TRIAL SPACER
• 00846468054373: DETACHABLE TRIAL SPACER
• 00846468054366: DETACHABLE TRIAL SPACER
• 00846468054359: DETACHABLE TRIAL SPACER
• 00846468054342: LOLLIPOP TRIAL SPACER