AccessGUDID - DEVICE: Vertex (00810005667289)

GUDID

Device Identifier (DI) Information

Brand Name: Vertex
Version or Model: STK-1000T-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00810005667289
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047486041 *Terms of Use

Device Description: Instrument: sizing guide body is 12-14 (multiple use). The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.

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:	No
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?
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182943	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a796d509-536e-45ca-b93b-450e536249b8
Public Version Date: January 05, 2021
Public Version Number: 1
DI Record Publish Date: December 28, 2020