AccessGUDID - DEVICE: EXPERT - Joint Fixation System (07899258642536)

GUDID

Device Identifier (DI) Information

Brand Name: EXPERT - Joint Fixation System
Version or Model: EXPERT Knotless Dual
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 314-2000
Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA

Primary DI Number: 07899258642536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 900865213 *Terms of Use

Device Description: EXPERT Knotless Dual Round Plate Ø6.5mm (2un) Rectangular Plate 3.5x13mm (2un) Support Plate for Syndesmosis 10mm x 40mm (1un)

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?
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTN	Washer, Bolt Nut

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200332	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44053e5d-2217-4268-b68f-3eb0ef84ec2f
Public Version Date: January 19, 2024
Public Version Number: 1
DI Record Publish Date: January 11, 2024