AccessGUDID - DEVICE: Coronet (00861445000334)

GUDID

Device Identifier (DI) Information

Brand Name: Coronet
Version or Model: FA01025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FA01025
Company Name: CONEXTIONS MEDICAL INC

Primary DI Number: 00861445000334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063692935 *Terms of Use

Device Description: The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.

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
HWC	Screw, Fixation, Bone
JDR	Staple, Fixation, Bone
KGS	Retention Device, Suture
MAI	Fastener, Fixation, Biodegradable, Soft Tissue
MBI	Fastener, Fixation, Nondegradable, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200028	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: e1dd5b2d-28de-4795-8538-877b9428bbc3
Public Version Date: July 08, 2020
Public Version Number: 1
DI Record Publish Date: June 30, 2020