AccessGUDID - DEVICE: COR-KNOT® QUICK LOAD® (00850200006056)

GUDID

Device Identifier (DI) Information

Brand Name: COR-KNOT® QUICK LOAD®
Version or Model: 030874
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 030874
Company Name: LSI Solutions, Inc.

Primary DI Number: 00850200006056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 603420183 *Terms of Use

Device Description: COR-KNOT® QUICK LOAD® 6-POUCH

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
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: 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: c3a090f1-c099-4780-9d8d-f97ec7f1629e
Public Version Date: November 16, 2022
Public Version Number: 2
DI Record Publish Date: October 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850200006053	12	00850200006056		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: 00850200006063 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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

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