Boomerang B070-D016

GUDID 00840996176651

Boomerang,Drill, 16MM

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840996176651
• NIH Device Record Key: d014d301-21ff-4b71-b39d-057f2a73bc1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boomerang
• Version Model Number: B070-D016
• Catalog Number: B070-D016
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: 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(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM
• Phone: +1(865)246-3333
• Email: INFO@CHOICESPINE.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996176651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190227

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

[00840996176651]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [Boomerang]

• 00840996177658: Fixed Handle Drill Guide, Boomerang
• 00840996176682: Boomerang Combo Inserter/Driver Coupler
• 00840996176675: BOOMERANG,COMBO INSERT/DRVR,OUTER SHAFT
• 00840996176668: BOOMERANG,DRILL,18MM
• 00840996176651: Boomerang,Drill, 16MM
• 00840996176644: BOOMERANG,DRILL,14MM
• 00840996176637: BOOMERANG,DRILL,12MM
• 00840996176620: BOOMERANG,ALIGNMENT BLOCK
• 00840996176613: Boomerang Drill Guide
• 00840996176545: BOOMERANG,SCREW,SELF-DRILLING,4.5X1
• 00840996176538: BOOMERANG SELF DRILLING SCREWS 4.5X 10MM
• 00840996176521: BOOMERANG SELF DRILLING SCREWS 4.0x17MM
• 00840996176514: BOOMERANG,SCREW,SELF-DRILLING,4.0X15
• 00840996176507: BOOMERANG SELD DRILLING SCREW 4.0X13MM
• 00840996176491: BOOMERANG,SCREW,SELF-DRILLING,4.0X11
• 00840996176484: Boomerang Small Offset Plate 19MM
• 00840996176477: Boomerang Small Offset Plate 17MM
• 00840996176460: Boomerang Small Offset Plate 15MM
• 00840996176453: BOOMERANG,SMALL OFFSET PLATE,15MM
• 00840996176446: Boomerang SMall Offset Plate 13MM
• 00840996176439: Boomerrang Small Offset Plate 11MM
• 00840996181242: BOOMERANG,SCREW,SELF-DRILLING,4.5X18
• 00840996181235: BOOMERANG,SCREW,SELF-DRILLING,4.5X16
• 00840996181228: BOOMERANG,SCREW,SELF-DRILLING,4.5X14
• 00840996181211: BOOMERANG,SCREW,SELF-DRILLING,4.5X12
• 00840996192392: BOOMERANG,ALIGNMENT BLOCK,3-IN-1
• 00840996175760: BOOMERANG,OFFSET PLATE,12MM