20GA Illuminating Laser Probe, SMA905

GUDID 10632307001946

20GA Illuminating Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide
Primary Device ID10632307001946
NIH Device Record Key2c48f275-06c8-4e22-8c3f-73ea3c24405f
Commercial Distribution StatusIn Commercial Distribution
Brand Name20GA Illuminating Laser Probe, SMA905
Version Model NumberGA-0040087
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

Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge
Device Size Text, specify0
Needle Gauge20 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307001949 [Primary]
GS110632307001946 [Package]
Contains: 00632307001949
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

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

[10632307001946]

Ethylene Oxide

Device Entry Metadata

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

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