DINAMIC T HUMERUS DT725320

GUDID 08032909626717

Kit composed of: - Humeral nail ø7mm L320mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136).

CITIEFFE SRL

Humerus nail

• Primary Device ID: 08032909626717
• NIH Device Record Key: e214a8a3-106d-4a4b-9bac-2307fb8904f1
• Commercial Distribution Discontinuation: 2016-10-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DINAMIC T HUMERUS
• Version Model Number: Long nail ø7mm L320mm, left
• Catalog Number: DT725320
• Company DUNS: 431406875
• Company Name: CITIEFFE 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com
• Phone: +39051721850
• Email: info@citieffe.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Length: 320 Millimeter
• Outer Diameter: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032909626717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113387

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2015-10-21

On-Brand Devices [DINAMIC T HUMERUS]

• 08032909629879: Nail extractor
• 08032909629862: Long nail impactor/extractor
• 08032909629770: Nail and screw ruler
• 08032909629855: Soft tissue protection sleeve for out-nail screws
• 08032909629824: Soft tissue protection sleeve
• 08032909629756: ø9mm cannula
• 08032909629909: Instrument tray for out-nail screws
• 08032909629893: Instrument tray
• 08032909626731: End cap for humeral nail. Lenght: 8mm (standard end cap + 8mm). Material: titanium alloy Ti6Al4V
• 08032909626724: End cap for humeral nail. Lenght: 8mm (standard end cap + 4mm). Material: titanium alloy Ti6Al4V
• 08032909625833: End cap for humeral nail. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909629831: Quick-connect T handle
• 08032909629718: Cannulated antegrade awl
• 08052990971510: Graduated guide wire with olive ø2.5mmx450mm
• 08052990970223: Kit composed of: - Humeral nail ø7mm L320mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970216: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970209: Kit composed of: - Humeral nail ø7mm L280mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970193: Kit composed of: - Humeral nail ø7mm L260mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970186: Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970179: Kit composed of: - Humeral nail ø7mm L220mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970162: Kit composed of: - Humeral nail ø7mm L200mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970155: Kit composed of: - Humeral nail ø7mm L320mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970148: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970131: Kit composed of: - Humeral nail ø7mm L280mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970124: Kit composed of: - Humeral nail ø7mm L260mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970117: Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970100: Kit composed of: - Humeral nail ø7mm L220mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970094: Kit composed of: - Humeral nail ø7mm L200mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08052990970087: Kit composed of: - Humeral nail ø7mm L150mm (1 pc); - Guide wire (3 pcs). Material of the nail:
• 08032909626717: Kit composed of: - Humeral nail ø7mm L320mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626700: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626694: Kit composed of: - Humeral nail ø7mm L280mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626687: Kit composed of: - Humeral nail ø7mm L260mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626670: Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626663: Kit composed of: - Humeral nail ø7mm L220mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626656: Kit composed of: - Humeral nail ø7mm L200mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626649: Kit composed of: - Humeral nail ø7mm L320mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626632: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626625: Kit composed of: - Humeral nail ø7mm L280mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626618: Kit composed of: - Humeral nail ø7mm L260mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626601: Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626595: Kit composed of: - Humeral nail ø7mm L220mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626588: Kit composed of: - Humeral nail ø7mm L200mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08032909626571: Kit composed of: - Humeral nail ø7mm L150mm (1 pc); - End cap (1 pc); - Guide wire (3 pcs). Mat
• 08052990972616: ø2.5mmx450mm graduated guide wire (sterile)
• 08032909629701: ø2.5mmx450mm graduated guide wire
• 08032909627356: Kirschner wire with trocar tip ø2.5mm L250mm. Material: stainless steel AISI 316L (ASTM F138).
• 08032909626984: Cephalic screw ø5mm L55mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909626977: Cephalic screw ø5mm L52.5mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
• 08032909626960: Cephalic screw ø5mm L50mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).