23GA Straight Laser Probe, SMA905

GUDID 10632307001748

23GA Straight Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID10632307001748
NIH Device Record Keye52d3d2f-a724-4bd5-abbd-031bd4604f3f
Commercial Distribution StatusIn Commercial Distribution
Brand Name23GA Straight Laser Probe, SMA905
Version Model NumberGA-0040009
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307001741 [Primary]
GS110632307001748 [Package]
Contains: 00632307001741
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307001748]

Ethylene Oxide


[10632307001748]

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 Straight Laser Probe, SMA905]

1063230700206623GA Straight Laser Probe, SMA905
1063230700174823GA Straight Laser Probe, SMA905

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