25GA Curved Illuminating Probe, SMA905

GUDID 10632307001700

25GA Curved Illuminating Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID10632307001700
NIH Device Record Key1030c1bd-be0f-4d4e-9576-ade693d6da8a
Commercial Distribution StatusIn Commercial Distribution
Brand Name25GA Curved Illuminating Probe, SMA905
Version Model NumberGA-0040005
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
GS100632307001703 [Primary]
GS110632307001700 [Package]
Contains: 00632307001703
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

[10632307001700]

Ethylene Oxide


[10632307001700]

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 [25GA Curved Illuminating Probe, SMA905]

1063230700192225GA Curved Illuminating Probe, SMA905
1063230700170025GA Curved Illuminating Probe, SMA905

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