23GA Curved Laser Probe, SMA905

GUDID 10632307002073

23GA Curved Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID10632307002073
NIH Device Record Keya4fd3aa5-4e89-460f-9e23-32e838d8d0c3
Commercial Distribution StatusIn Commercial Distribution
Brand Name23GA Curved Laser Probe, SMA905
Version Model NumberGA-0042220
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

Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307002076 [Primary]
GS110632307002073 [Package]
Contains: 00632307002076
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

[10632307002073]

Ethylene Oxide


[10632307002073]

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 Curved Laser Probe, SMA905]

1063230700207323GA Curved Laser Probe, SMA905
1063230700166323GA Curved Laser Probe, SMA905

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