AccessGUDID - DEVICE: ST.A.R. 90 F4 (08052990978083)

GUDID

Device Identifier (DI) Information

Brand Name: ST.A.R. 90 F4
Version or Model: HA cortical bone screw ø3mm L60-20mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST025360HA
Company Name: CITIEFFE SRL

Primary DI Number: 08052990978083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431406875 *Terms of Use

Device Description: Cortical bone screw with hydroxyapatite coating ø3mm L60mm-Thread L20mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609).

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:	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?
48011	External orthopaedic fixation system, single-use	An assembly of devices designed to stabilize fractured bones 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, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDW	Pin, Fixation, Threaded

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150661	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
Length: 60 Millimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: 8007edd5-e34c-4dbb-b7f6-be20884617ee
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024