AccessGUDID - DEVICE: 25GA Curved Illuminating Laser Probe

GUDID

Device Identifier (DI) Information

Brand Name: 25GA Curved Illuminating Laser Probe - Iridex
Version or Model: PD725.37
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Peregrine Surgical, Llc

Primary DI Number: 00632307000898
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622467348 *Terms of Use

Device Description: 25GA Curved Illuminating Laser Probe - Iridex

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":	Yes
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?
61162	Ophthalmic laser system beam guide	A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 Gauge Needle
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: ae504ae4-620e-43f2-8a87-2ce63608c481
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: May 06, 2016