ONCONTROL 9468-VC-006

GUDID 30816000014012

TELEFLEX INCORPORATED

Bone marrow biopsy needle, single-use

• Primary Device ID: 30816000014012
• NIH Device Record Key: fd651a52-f8c4-421b-a3b8-4cf566a6bd16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONCONTROL
• Version Model Number: IPN928568
• Catalog Number: 9468-VC-006
• 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: 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(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	10816000014018 [Primary]
GS1	20816000014015 [Package]; Contains: 10816000014018; Package: Box [6 Units]; In Commercial Distribution
GS1	30816000014012 [Package]; Contains: 20816000014015; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• FCG: Biopsy needle

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: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [ONCONTROL]

• 20841156108677: OnControl® Bone Marrow Biopsy System Tray, 102mm
• 20841156108653: OnControl® Aspiration System Tray, 102mm
• 20841156108622: OnControl® Bone Lesion Biopsy System Tray 11ga 6cm / 13ga 10cm (6/BX)
• 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)
• 20841156108493: OnControl® Bone Marrow Biopsy System Comprehensive Tray, 152mm (6/BX)
• 20841156108479: OnControl® Bone Marrow Biopsy System Tray, 152mm
• 20841156108660: OnControl® Aspiration System Needle Set, 90mm
• 30841156108636: OnControl® Aspiration System Needle Set, 68mm
• 20841156108592: OnControl® Bone Lesion Biopsy System Tray 10ga 6cm / 12ga 10cm (1/BX)
• 30841156108483: OnControl® Aspiration System Needle Set, 25mm
• 20841156108646: OnControl® Ported Aspiration System Tray, 102mm
• 20841156108523: OnControl® Bone Lesion Biopsy System Tray 10ga 15cm / 12ga 19cm (6/BX)
• 30841156108469: OnControl® Bone Marrow Biopsy System Needle Set, 102mm
• 20841156108455: OnControl® System Sterile Procedure Tray
• 30841156108445: OnControl® Bone Marrow Biopsy System Needle Set, 152mm
• 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
• 20841156110892: OnControl (R) Ported Aspiration System Tray, 102mm
• 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
• 20841156110908: OnControl(R) Aspiration System Needle Set, 90mm
• 30841156111032: IPN928569
• 30816000014012: IPN928568