AccessGUDID - DEVICE: COR-KNOT MINI® (00850200006087)

GUDID

Device Identifier (DI) Information

Brand Name: COR-KNOT MINI®
Version or Model: 031350
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006087
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: COR-KNOT MINI® COMBO KIT Base Package Type - Kit Each sterile package kit contains (2) single patient use COR-KNOT MINI® Devices and (12) COR-KNOT® QUICK LOADS®.

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:	Yes
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?
61353	Suture clasp, non-bioabsorbable	A small, sterile, implantable fastening device designed to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. It is made of non-bioabsorbable materials [e.g., titanium (Ti)] and is typically implanted with a dedicated applicator.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HCF	Instrument, Ligature Passing And Knot Tying

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100593	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 14 Centimeter
Outer Diameter: 4 Millimeter

Device Record Status

Public Device Record Key: 5b396434-96c7-4d8b-a70a-44b3c0ce1880
Public Version Date: July 16, 2020
Public Version Number: 4
DI Record Publish Date: December 04, 2015