Pennig Dynamic Wrist Fixator 99-37101

GUDID 18033509850752

SELF-DRILL PENNIG CORT. SCREW STERILE L 70/30 MM THREAD D 3.3-3.0 MM

ORTHOFIX SRL

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 18033509850752
• NIH Device Record Key: dc9cb749-ffcd-418a-9126-8989a4acdfa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pennig Dynamic Wrist Fixator
• Version Model Number: 1
• Catalog Number: 99-37101
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• Manufacturing Date: true
• 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: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033509850752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [Pennig Dynamic Wrist Fixator]

• 18054242510918: DRILL BIT D.2,7 MM L.127 MM TIN COATED - QUICK CONNECT
• 18033509858253: PAEDIATRIC FIXATOR SHORT BODY WITH T-CLAMP
• 18033509850769: SELF-DRILL PENNIG CORT. SCREW STERILE L 100/30 MM THREAD D 3.3-3 MM
• 18033509850752: SELF-DRILL PENNIG CORT. SCREW STERILE L 70/30 MM THREAD D 3.3-3.0 MM
• 18033509850745: SELF-DRILL PENNIG CORT. SCREW STERILE L 60/20 MM THREAD D 3.3-3.0 MM
• 18033509850738: PENNIG CORTICAL SCREW 70/20 MM STERILE SHAFT D 4MM THREAD D 3.0-2.5MM
• 18033509850721: PENNIG CORTICAL SCREW 80/35 MM STERILE SHAFT D 4MM THREAD D 3.3-3.0MM
• 18033509850714: PENNIG CORTICAL SCREW 70/20 MM STERILE SHAFT D 4MM THREAD D 3.3-3.0MM
• 18032568866582: SPECIAL PENNIG CLAMP KIT
• 18032568864557: SELFDRILLING CORTICAL SCREW 90/20 MM THREAD DIA.3.3-3 MM
• 18032568864533: PEDIATRIC FIXATOR STRAIGHT CONFIGURATION
• 18032568036299: SELF-DRILL PENNIG CORT. SCREW L 100/30 MM THREAD D 3.3-3 MM
• 18032568036282: SELF-DRILL PENNIG CORT. SCREW L 70/30 MM THREAD D 3.3-3.0 MM
• 18032568036275: SELF-DRILL PENNIG CORT. SCREW L 60/20 MM THREAD D 3.3-3.0 MM
• 18032568036268: T-CLAMP PENNIG DYNAMIC WRIST FIXATOR
• 18032568036251: CLAMP COVER/ANCHORING SCREW PENNIG DYNAMIC WRIST FIXATOR
• 18032568036244: RE-USE KIT (3 CLAMP COVER SCREWS)
• 18032568036237: EXTRA ARTICULAR RADIOLUCENT WRIST CLAMP
• 18032568036220: COMPR/DISTR.MODULE COMPLETE PENNIG DYNAMIC WRIST FIXATOR
• 18032568036213: ULNAR OUTRIGGER CLAMP PENNIG DYNAMIC WRIST FIXATOR
• 18032568036206: STRAIGHT CLAMP PENNIG DYNAMIC WRIST FIXATOR
• 18032568036190: DOUBLE BALL-JOINT PENNIG DYNAMIC WRIST FIXATOR
• 18032568036183: LONG MODULE (COMPLETE) PENNIG DYNAMIC WRIST FIXATOR
• 18032568036176: SHORT MODULE WITH T-CLAMP PENNIG DYNAMIC WRIST FIXATOR
• 18032568036169: SHORT MODULE (COMPLETE) PENNIG DYNAMIC WRIST FIXATOR
• 18032568036152: RE-PACK KIT PENNIG DYNAMIC WRIST FIXATOR
• 18032568036145: BUSH PENNIG DYNAMIC WRIST FIXATOR
• 18032568036138: CAM PENNIG DYNAMIC WRIST FIXATOR
• 18032568036121: PENNIG DYNAMIC WRIST FIXATOR FOR EXTRA ARTICULAR FRACTURES
• 18032568036114: PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT
• 18032568036107: PENNIG DYNAMIC WRIST FIXATOR
• 18032568035988: STERILIZABLE SCREW COVER FOR PENNIG (PACK OF 20)
• 18032568035964: PENNIG CORTICAL SCREW 70/20 MM SHAFT D 4MM THREAD D 3.0-2.5MM
• 18032568035957: PENNIG CORTICAL SCREW 80/35 MM SHAFT D 4MM THREAD D 3.3-3.0MM
• 18032568035940: PENNIG CORTICAL SCREW 70/20 MM SHAFT D 4MM THREAD D 3.3-3.0MM
• 18032568033274: PENNIG STERI BOX EMPTY
• 18032568033267: KIRSCHNER WIRE (PACK OF 2) LENGTH 150 MM DIAMETER 1.5 MM
• 18032568033250: PENNIG DYNAMIC WRIST FIXATOR TEMPLATE/CONVERSION CLAMP
• 18032568033243: PENNIG DYNAMIC WRIST FIXATOR ASSEMBLY TEMPLATE KIT
• 18032568033199: T-WRENCH FOR CLAMP SCREWS
• 18032568033175: WRIST KIT FOR SMALL METACARPAL
• 18032568033168: DRILL BIT STOP UNIT D 2 MM
• 18032568033151: DRILL BIT DIAMETER 2.0 MM LENGTH 127 MM
• 18032568033144: DRILL BIT KIT DIAMETER 2.0 MM LENGTH 127 MM
• 18032568033137: DRILL BIT DIAMETER 2.7 MM LENGTH 127 MM
• 18032568033120: DRILL BIT KIT DIAMETER 2.7 MM LENGTH 127 MM
• 18032568033113: TAPERED TROCAR
• 18032568033106: PILOT WIRE GUIDE D 1.6 MM
• 18032568033090: DRILL GUIDE DIAMETER 2.0 MM
• 18032568033083: DRILL GUIDE DIAMETER 2.7 MM