ONCONTROL 9401

GUDID 20841156108431

OnControl® Power Driver

TELEFLEX INCORPORATED

Intraosseous-access handpiece, infusion, electric

• Primary Device ID: 20841156108431
• NIH Device Record Key: e687e75b-2e66-45a1-bb28-7391851176e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONCONTROL
• Version Model Number: IPN919011
• Catalog Number: 9401
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156108434 [Primary]
GS1	20841156108431 [Package]; Contains: 10841156108434; Package: Case [1 Units]; In Commercial Distribution

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

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• 20841156108608: OnControl® Bone Lesion Biopsy System Tray 10ga 6cm / 12ga 10cm (6/BX)
• 20841156108585: OnControl® Bone Lesion Biopsy System Tray 11ga 10cm / 13ga 14cm (6/BX)
• 20841156108561: OnControl® Bone Lesion Biopsy System Tray 10ga 10cm / 12ga 14cm (6/BX)
• 20841156108547: OnControl® Bone Lesion Biopsy System Tray 11ga 15cm / 13ga 19cm (6/BX)
• 20841156108509: OnControl® Bone Marrow Biopsy System Comprehensive Tray, 102mm (6/BX)
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• 30841156108469: OnControl® Bone Marrow Biopsy System Needle Set, 102mm
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• 20841156108431: OnControl® Power Driver
• 20841156111011: ONCONTROL(R) ASPIRATION TRAY, 102MM
• 20841156111004: ONCONTROL(R) COAXIAL BIOPSY TRAY 11/13 GA
• 20841156110991: ONCONTROL(R) COAXIAL BIOPSY TRAY 10/12 GA
• 20841156110984: ONCONTROL (R) COAXIAL BIOPSY TRAY 10/12 GA
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• 20841156110885: OnControl (R) Bone Lesion Biopsy System Tray 11ga 10cm / 13ga 14cm (6/BX)
• 20841156110878: OnControl (R) Bone Marrow Biopsy System Tray, 152mm
• 20841156110861: OnControl (R) Bone Marrow Biopsy System Tray, 102mm
• 20841156110939: OnControl (R) Bone Lesion Biopsy System Tray 11ga 15cm / 13ga 19cm (6/BX)
• 20841156110922: OnControl (R) Bone Lesion Biopsy System Tray 10ga 15cm / 12ga 19cm (6/BX)
• 20841156110915: OnControl (R) Bone Marrow Biopsy System Needle Set, 152mm
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• 30841156111032: IPN928569
• 30816000014012: IPN928568