AccessGUDID - DEVICE: EXPERT - Flexible Joint Fixation System (07899258663838)

GUDID

Device Identifier (DI) Information

Brand Name: EXPERT - Flexible Joint Fixation System
Version or Model: EXPERT ACL TIBIAL TAPE - 17mm/7mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 312-9000
Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA

Primary DI Number: 07899258663838
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 900865213 *Terms of Use

Device Description: EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave button 17mm /7mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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 [?]
K242311	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: 4efde3c2-5960-4e78-88c3-6c32cf4e5800
Public Version Date: November 13, 2024
Public Version Number: 1
DI Record Publish Date: November 05, 2024