23GA Illuminating Laser Probe, SMA905

GUDID 10632307001694

23GA Illuminating Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID10632307001694
NIH Device Record Keyb4d63846-b315-4187-a599-fb1dc4e2d05f
Commercial Distribution StatusIn Commercial Distribution
Brand Name23GA Illuminating Laser Probe, SMA905
Version Model NumberGA-0040004
Company DUNS622467348
Company NamePEREGRINE SURGICAL, LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(215)348-0456
Emailjayne@peregrine-surgical.com
Phone+1(215)348-0456
Emailjayne@peregrine-surgical.com

Device Dimensions

Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307001697 [Primary]
GS110632307001694 [Package]
Contains: 00632307001697
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307001694]

Ethylene Oxide


[10632307001694]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [23GA Illuminating Laser Probe, SMA905]

1063230700208023GA Illuminating Laser Probe, SMA905
1063230700191523GA Illuminating Laser Probe, SMA905
1063230700169423GA Illuminating Laser Probe, SMA905

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