AccessGUDID - DEVICE: COR-KNOT MICRO™ (00850200006933)

GUDID

Device Identifier (DI) Information

Brand Name: COR-KNOT MICRO™
Version or Model: 032500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 032500
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006933
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: COR-KNOT MICRO™ DEVICE Pre-Loaded with (1) titanium COR-KNOT MICRO™ FASTENER

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?
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
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202551	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
Length: 14 Centimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: cf120bc8-0efa-44c6-b121-038b27d3f42a
Public Version Date: November 07, 2022
Public Version Number: 3
DI Record Publish Date: July 14, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850200006930	6	00850200006933		In Commercial Distribution	Inner pack

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)575-3493
Email: regulatorydpt@lsisolutions.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES