FDA.reportPublic FDA data

27GA Curved Illuminating Laser Probe - Iridex

Primary DI
00632307002342
Brand
27GA Curved Illuminating Laser Probe - Iridex
Company
Peregrine Surgical, Llc
Model
7627.IRI-00
Device description
27GA Curved Illuminating Laser Probe - Iridex
Published
2024-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQBPHOTOCOAGULATOR AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132614000PEREGRINE CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.2013-11-14HQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307002349PackageGS16In Commercial Distribution
00632307002342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700234910632307002349
00632307002342006323070023426323070023420632307002342

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Needle Gauge27Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(215)348-0456ryan@peregrine-surgical.com

Regulatory Flags#

DUNS number
622467348
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0063230700214460 Degree DMEK/DSAEK ForcepsPD427.602020-08-14
00632307002212DMEK/DSAEK ForcepsPD427.002018-03-23
00632307002236DMEK ForcepsPD427.002018-05-15
00632307002250DMEK/DSAEK ForcepsPD427.002018-10-18
0063230700232827GA Curved Illuminating Laser Probe - DORC7627.DORC-002024-09-24
0063230700235925GA Midfield Endoillumination Probe3269.M05-002024-09-24
0063230700236627GA Midfield Endoillumination Probe3269.M04-002024-09-24
0063230700237323GA Midfield Endoillumination Probe3269.M06-002024-09-24
1063230700232527GA Curved Illuminating Laser Probe - DORC7627.DORC-002024-09-24
0063230700233527GA Curved Illuminating Laser Probe - Alcon7627.ALC-002024-09-24
1063230700234927GA Curved Illuminating Laser Probe - Iridex7627.IRI-002024-09-24
1063230700235625GA Midfield Endoillumination Probe3269.M05-002024-09-24
1063230700236327GA Midfield Endoillumination Probe3269.M04-002024-09-24
1063230700237023GA Midfield Endoillumination Probe3269.M06-002024-09-24
0063230700000320GA Straight Laser Probe - AlconPD720.102016-05-06
0063230700001020GA Membrane ScraperPD800.002016-05-06
0063230700002720GA Non-Adjustable Membrane ScraperPD800.202016-05-06
0063230700003423GA Membrane ScraperPD800.232016-05-06
0063230700004123GA Flexible Membrane ScraperPD800.23SF2016-05-06
0063230700005825GA Membrane ScraperPD800.252016-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M735A5026001NAOPHTHALMED LLCHQB2022-09-22
M735A5027001NAOPHTHALMED LLCHQB2022-09-22
M735A5036001NAOPHTHALMED LLCHQB2022-09-22
M735A5037001NAOPHTHALMED LLCHQB2022-09-22
13700773703743FLEX CURVED LASER PROBE COMPATIBLE WITH Iridex / Bausch & Lomb™ 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703750FLEX CURVED LASER PROBE COMPATIBLE WITH Alcon® / Coherent / Zeiss / Ellex / OS4®FCI S A S FCI 20 22HQB2021-05-30
13700773703767CURVED LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773703774FLEX CURVED LASER PROBE COMPATIBLE WITH NIDEK THREAD 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703781FLEX CURVED LASER PROBE COMPATIBLE WITH DORC 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773720047STRAIGHT LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720054STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720061STRAIGHT LASER PROBE, 20G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720078STRAIGHT LASER PROBE, 20G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720085STRAIGHT LASER PROBE, 20G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720092STRAIGHT LASER PROBE, 23G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720108STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720115STRAIGHT LASER PROBE, 23G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720122STRAIGHT LASER PROBE, 23G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720139STRAIGHT LASER PROBE, 23G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720146STRAIGHT LASER PROBE, 25G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720153STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720160STRAIGHT LASER PROBE, 25G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720177STRAIGHT LASER PROBE, 25G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720184STRAIGHT LASER PROBE, 25G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720191STRAIGHT LASER PROBE, 27G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720207STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720214STRAIGHT LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720221STRAIGHT LASER PROBE, 27G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720238STRAIGHT LASER PROBE, 27G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720245CURVED LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30