AccessGUDID - DEVICE: LacriCATH (20634624438518)

GUDID

Device Identifier (DI) Information

Brand Name: LacriCATH
Version or Model: DCR508-UNIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QUEST MEDICAL INC

Primary DI Number: 20634624438518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041810693 *Terms of Use

Device Description: LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device, and one LIS052 STENTube intubation device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
47929	Lacrimal intubation set	A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OKS	Lacrimal Stents And Intubation Sets

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113867	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: 54871cd8-c5e8-4100-b37e-8b1625769563
Public Version Date: December 11, 2019
Public Version Number: 4
DI Record Publish Date: May 18, 2016