AccessGUDID - DEVICE: DINAMIC T HUMERUS (08032909626717)

GUDID

Device Identifier (DI) Information

Brand Name: DINAMIC T HUMERUS
Version or Model: Long nail ø7mm L320mm, left
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DT725320
Company Name: CITIEFFE SRL

Primary DI Number: 08032909626717
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 431406875 *Terms of Use

Device Description: 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).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38153	Humerus intramedullary nail	A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize the ends of a fractured bone in position to promote healing; it may also be used to support the bone in the presence of a pathological condition. It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113387	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Dry and clean environment and avoid damaging the packing. Room temperature.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8 Millimeter
Outer Diameter: 10 Millimeter
Device Size Text, specify: Left
Length: 320 Millimeter
Outer Diameter: 7 Millimeter

Device Record Status

Public Device Record Key: e214a8a3-106d-4a4b-9bac-2307fb8904f1
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: October 21, 2015