PENNIG MINIFIXATOR M412

GUDID 18032568867084

NUT, COMPRESSION/DISTRACTION

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 18032568867084
• NIH Device Record Key: 12eb4f1a-6cf1-49a4-b1df-8b25cfb6c9a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENNIG MINIFIXATOR
• Version Model Number: 1
• Catalog Number: M412
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568867084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18032568867084]

Moist Heat or Steam Sterilization

[18032568867084]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-04-19

On-Brand Devices [PENNIG MINIFIXATOR]

• 18033509851926: PMF THREADED WIRES D 2.0 MM STERILE LENGTH 100/15 MM (PACK OF 4)
• 18033509851919: PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4)
• 18032568867190: PENNIG MINIFIXATOR STERI BOX EMPTY
• 18032568867183: THREADED, WIRE EXTRACTOR
• 18032568867176: REDUCTION FORCEPS (2 PAIRS) FOR PENNIG MINIFIXATOR
• 18032568867169: PMF, THREADED WIRES, D 2.0 MM LENGTH 100/15 MM (PACK OF 4)
• 18032568867152: PMF, THREADED WIRES, D 1.6 MM LENGTH 70/15 MM (PACK OF 4)
• 18032568867145: PENNIG MINIFIXATOR SPACER
• 18032568867138: LENGTHENING BAR, LONG, 120 MM FOR PENNIG MINIFIXATOR
• 18032568867121: LENGTHENING BAR, STD, 100 MM FOR PENNIG MINIFIXATOR
• 18032568867114: LENGTHENING BAR, SHORT, 80 MM FOR PENNIG MINIFIXATOR
• 18032568867091: CLAMP, LOCKING SCREW FOR PENNIG MINIFIXATOR
• 18032568867084: NUT, COMPRESSION/DISTRACTION
• 18032568867077: CLAMPS, STANDARD, (ONE PAIR) FOR PENNIG MINIFIXATOR
• 18032568867060: L-CLAMPS (LEFT/RIGHT SET) FOR PENNIG MINIFIXATOR
• 18032568867053: PMF, EXTRA LONG BODY
• 18032568867046: PENNIG MINIFIXATOR LONG KIT
• 18032568867039: PENNIG MINIFIXATOR STD KIT
• 18032568867022: PENNIG MINIFIXATOR SHORT KIT
• 18032568867015: PENNIG MINIFIXATOR LONG BODY
• 18032568867008: PENNIG MINIFIXATOR, STD, BODY
• 18032568866995: PENNIG MINIFIXATOR, SHORT, BODY
• 18032568866346: MINI PENNIG ARTICULATED BODY
• 18032568865011: PMF, 3MM SCREW CLAMP (PAIR)
• 18032568865004: PMF LENGTHENING BAR 150 MM
• 18053504367765: Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.