23GA Alcon Illuminating Laser Probe - Alcon - Short

GUDID 10632307000451

23GA Alcon Illuminating Laser Probe - Alcon - Short

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide
Primary Device ID10632307000451
NIH Device Record Keyf2edfb42-dc09-4369-90bf-b04877965228
Commercial Distribution StatusIn Commercial Distribution
Brand Name23GA Alcon Illuminating Laser Probe - Alcon - Short
Version Model NumberPD723.30SA
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
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0
Needle Gauge23 Gauge
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307000454 [Primary]
GS110632307000451 [Package]
Contains: 00632307000454
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

[10632307000451]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-06

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