25GA Midfield Endoillumination Probe

GUDID 10632307002356

25GA Midfield Endoillumination Probe

Peregrine Surgical, Llc

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10632307002356
NIH Device Record Key5292db4e-24b2-4c71-a212-8bff8654d91b
Commercial Distribution StatusIn Commercial Distribution
Brand Name25GA Midfield Endoillumination Probe
Version Model Number3269.M05-00
Company DUNS622467348
Company NamePeregrine Surgical, Llc
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 Datefalse
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
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com
Phone+1(215)348-0456
Emailryan@peregrine-surgical.com

Device Dimensions

Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100632307002359 [Primary]
GS110632307002356 [Package]
Contains: 00632307002359
Package: Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJMTransilluminator, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

[10632307002356]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-02
Device Publish Date2024-09-24

Devices Manufactured by Peregrine Surgical, Llc

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00632307002335 - 27GA Curved Illuminating Laser Probe - Alcon2024-10-02 27GA Curved Illuminating Laser Probe - Alcon
10632307002349 - 27GA Curved Illuminating Laser Probe - Iridex2024-10-02 27GA Curved Illuminating Laser Probe - Iridex
10632307002356 - 25GA Midfield Endoillumination Probe2024-10-0225GA Midfield Endoillumination Probe
10632307002356 - 25GA Midfield Endoillumination Probe2024-10-02 25GA Midfield Endoillumination Probe
10632307002363 - 27GA Midfield Endoillumination Probe2024-10-02 27GA Midfield Endoillumination Probe
10632307002370 - 23GA Midfield Endoillumination Probe2024-10-02 23GA Midfield Endoillumination Probe
10632307002264 - 23GA Straight Pick2024-09-11 23GA Straight Pick
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