AccessGUDID - DEVICE: GEO Bone Screw System (B471711300020)

GUDID

Device Identifier (DI) Information

Brand Name: GEO Bone Screw System
Version or Model: 71130002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC

Primary DI Number: B471711300020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080068420 *Terms of Use

Device Description: K-Wire Pack (2) 1.2mmx100mm for 3mm Bone Screw

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?
35685	Orthopaedic bone wire	A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRN	Wire, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161904	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
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.2 Millimeter

Device Record Status

Public Device Record Key: 46e0ef4b-99a0-4b9d-bff1-e168dba83c3f
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: October 10, 2018