AccessGUDID - DEVICE: EAGLE VISION MONOSTENT-P (00844505010023)

GUDID

Device Identifier (DI) Information

Brand Name: EAGLE VISION MONOSTENT-P
Version or Model: 1084
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EAGLE VISION, INC.

Primary DI Number: 00844505010023
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 174318360 *Terms of Use

Device Description: MONOSTENT - MONOCANALICULAR STENT-P, TUBING:50MM X 0.64MM OD, SILICONE

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?
10575	Lacrimal procedural cannula	A hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. 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 [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 0.64 Millimeter
Length: 50 Millimeter

Device Record Status

Public Device Record Key: 0550116d-6a51-4a11-ac58-cb04eba696d8
Public Version Date: December 11, 2019
Public Version Number: 3
DI Record Publish Date: October 12, 2015