Pennig Dynamic Wrist Fixator 13550

GUDID 18032568033120

DRILL BIT KIT DIAMETER 2.7 MM LENGTH 127 MM

ORTHOFIX SRL

Fluted surgical drill bit, reusable
Primary Device ID18032568033120
NIH Device Record Key2f07f121-843c-4fbe-ad48-77500bc10826
Commercial Distribution StatusIn Commercial Distribution
Brand NamePennig Dynamic Wrist Fixator
Version Model Number1
Catalog Number13550
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Dimensions

Outer Diameter2.7 Millimeter
Length127 Millimeter
Outer Diameter2.7 Millimeter
Length127 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568033120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568033120]

Moist Heat or Steam Sterilization


[18032568033120]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-09-16

On-Brand Devices [Pennig Dynamic Wrist Fixator ]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.