SMALL BLUE D.A.F. 13136

GUDID 18032568033038

SELF-ALIGNING ARTIC. TEMPLATE FOR SMALL DAF

ORTHOFIX SRL

External orthopaedic fixation system, reusable

• Primary Device ID: 18032568033038
• NIH Device Record Key: 4b885cf3-e80a-4d13-adf9-5ab3f01b0d16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMALL BLUE D.A.F.
• Version Model Number: 1
• Catalog Number: 13136
• 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: 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	18032568033038 [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

[18032568033038]

Moist Heat or Steam Sterilization

[18032568033038]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

On-Brand Devices [SMALL BLUE D.A.F. ]

• 18032568864502: SMALL D.A.F. INDEPENDENT SCREW CLAMP
• 18032568035773: CLAMP COVER (BLUE SMALL DAF)
• 18032568035766: DOUBLE COUPLING CLAMP FOR BLUE SMALL DAF
• 18032568035759: SMALL BLUE DAF T-CLAMP
• 18032568035742: SMALL BLUE DAF STRAIGHT CLAMP
• 18032568035735: SMALL BLUE DAF BUSH
• 18032568035728: BLUE SMALL D.A.F.COMPLETE BODY
• 18032568035711: SMALL BLUE DAF
• 18032568035704: SELF-ALIGNING ARTICULATED BODY FOR SMALL DAF
• 18032568035698: SILICONE O-RINGS (PACK OF 10) FOR C/D UNIT FOR SMALL DAF
• 18032568035681: CLAMP COVER FOR SMALL DAF
• 18032568035674: TORQUE WRENCH 5 MM
• 18032568035643: SMALL DAF CENTRAL COMPONENT
• 18032568035636: SMALL DAF FEMALE COMPONENT
• 18032568035629: SMALL DAF MALE COMPONENT
• 18032568035612: ALLEN WRENCH 5 MM
• 18032568035605: CENTRAL BODY LOCKING NUT FOR SMALL DAF
• 18032568035599: CLAMP SCREW
• 18032568035582: COMPRESSION DISTRACTION UNIT EXTENDS TO 5 CM
• 18032568035544: CAM
• 18032568033045: MANIPULATION FORCEPS SELF LOCKING
• 18032568033038: SELF-ALIGNING ARTIC. TEMPLATE FOR SMALL DAF
• 18032568032987: SMALL DAF BODY TEMPLATE
• 18032568032970: TEMPLATE FOR SMALL DAF STRAIGHT/T-CLAMP
• 18032568032963: DRILL GUIDE DIAMETER 2.9 MM LENGTH 20 MM
• 18032568032956: DRILL GUIDE DIAMETER 3.2 MM LENGTH 20 MM
• 18032568032949: SCREW GUIDE LENGTH 32 MM
• 18032568032932: SMALL DAF ASSEMBLY TEMPLATE
• 18032568032925: SMALL DAF TEMPLATE KIT
• 18032568032888: DRILL BIT DIAMETER 2.9 MM LENGTH 140 MM
• 18053504366270: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504365686: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364412: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364405: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364061: Component. Not for sale. Used for reporting Direct Marking of assembly.
• 18053504364054: Component. Not for sale. Used for reporting Direct Marking of assembly.