AccessGUDID - DEVICE: 20GA Tapered Diffusion Light Pipe

GUDID

Device Identifier (DI) Information

Brand Name: 20GA Tapered Diffusion Light Pipe - 287 Connector
Version or Model: PD101.14
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Peregrine Surgical, Llc

Primary DI Number: 00632307001154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622467348 *Terms of Use

Device Description: 20GA Tapered Diffusion Light Pipe - 287 Connector

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?
45193	Ophthalmic fibreoptic light instrument, single-use	A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPA	Endoilluminator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980025	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
Needle Gauge: 20 Gauge
Device Size Text, specify: 20 Gauge Needle

Device Record Status

Public Device Record Key: 36169808-ec31-4fd3-b7f4-73fa6bb67614
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: May 06, 2016