AccessGUDID - DEVICE: DOLPHIX (08052990972586)

GUDID

Device Identifier (DI) Information

Brand Name: DOLPHIX
Version or Model: Soft tissue protection guide
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF900025
Company Name: CITIEFFE SRL

Primary DI Number: 08052990972586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431406875 *Terms of Use

Device Description: Surgical guide for pre-drill wire insertion with soft tissue protection. Material: titanium alloy Ti6Al4V ELI (ASTM F136).

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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?
48012	External orthopaedic fixation system, single-use, sterile	An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
JDW	Pin, Fixation, Threaded

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163323	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
No Device Sizes

Device Record Status

Public Device Record Key: a898158e-92d2-4d17-a31f-11deff6584f7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 19, 2017