AccessGUDID - DEVICE: ST.A.R. 90 F4 (08056711920047)

GUDID

Device Identifier (DI) Information

Brand Name: ST.A.R. 90 F4
Version or Model: HA cortical bone screw ø6mm L150-30mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST360148HA
Company Name: CITIEFFE SRL

Primary DI Number: 08056711920047
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 ø6mm L150mm - Thread L30mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated.

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
Outer Diameter: 6 Millimeter
Length: 150 Millimeter

Device Record Status

Public Device Record Key: 758b141c-98b7-4585-81f8-f69d4e316792
Public Version Date: July 07, 2022
Public Version Number: 1
DI Record Publish Date: June 29, 2022