27GA Curved Illuminating Laser Probe - Iridex

GUDID 10632307002349

27GA Curved Illuminating Laser Probe - Iridex

Peregrine Surgical, Llc

Ophthalmic laser system beam guide
Primary Device ID10632307002349
NIH Device Record Key2d432fec-4571-4f6e-b375-159700b2ee08
Commercial Distribution StatusIn Commercial Distribution
Brand Name27GA Curved Illuminating Laser Probe - Iridex
Version Model Number7627.IRI-00
Company DUNS622467348
Company NamePeregrine Surgical, Llc
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
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com

Device Dimensions

Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge
Device Size Text, specify0
Needle Gauge27 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307002342 [Primary]
GS110632307002349 [Package]
Contains: 00632307002342
Package: Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQBPHOTOCOAGULATOR AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-02
Device Publish Date2024-09-24

Devices Manufactured by Peregrine Surgical, Llc

10632307002325 - 27GA Curved Illuminating Laser Probe - DORC2024-10-02 27GA Curved Illuminating Laser Probe - DORC
00632307002335 - 27GA Curved Illuminating Laser Probe - Alcon2024-10-02 27GA Curved Illuminating Laser Probe - Alcon
10632307002349 - 27GA Curved Illuminating Laser Probe - Iridex2024-10-0227GA Curved Illuminating Laser Probe - Iridex
10632307002349 - 27GA Curved Illuminating Laser Probe - Iridex2024-10-02 27GA Curved Illuminating Laser Probe - Iridex
10632307002356 - 25GA Midfield Endoillumination Probe2024-10-02 25GA Midfield Endoillumination Probe
10632307002363 - 27GA Midfield Endoillumination Probe2024-10-02 27GA Midfield Endoillumination Probe
10632307002370 - 23GA Midfield Endoillumination Probe2024-10-02 23GA Midfield Endoillumination Probe
10632307002264 - 23GA Straight Pick2024-09-11 23GA Straight Pick
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