AccessGUDID - DEVICE: I.CO.S (10381780046226)

GUDID

Device Identifier (DI) Information

Brand Name: I.CO.S
Version or Model: 105675ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 105675ND
Company Name: NEWDEAL

Primary DI Number: 10381780046226
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. It is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile and it is made from titanium alloy.

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":	Yes
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?
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6.5mm diam. x 75mm length

Device Record Status

Public Device Record Key: 9d9a7dd4-70d6-4ca9-9163-b46a46b3d403
Public Version Date: April 28, 2025
Public Version Number: 7
DI Record Publish Date: October 09, 2017