AccessGUDID - DEVICE: LSO QuickSet (00871321002215)

GUDID

Device Identifier (DI) Information

Brand Name: LSO QuickSet
Version or Model: LQ2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: Labtician Ophthalmics, Inc

Primary DI Number: 00871321002215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 248911026 *Terms of Use

Device Description: A device adapter that connects VFI machines to a syringe, providing pressurized air in assisting clinicians in depressing syringe.

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:	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?
47240	Ophthalmic irrigation/infusion/aspiration tubing, single-use	A length of flexible, noninvasive tube intended to connect an ophthalmic cannula to an external device(s) [e.g., pump, bottles] for infusion, irrigation and/or aspiration (suction) during an ophthalmic procedure [e.g., tamponade, glaucoma treatment]. It is made of polymer material(s), may incorporate single- or double-lumen and may be provided in rolls from which required lengths are cut, or in predetermined lengths. It may be provided with simple connectors; however, it does not include other associated items (e.g., clamp, spike) [i.e., not a tubing set]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQG	Adaptor, Holder, Syringe

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: cd108d8f-7799-446c-a2b4-f94e40cfe8de
Public Version Date: January 27, 2021
Public Version Number: 6
DI Record Publish Date: February 26, 2018