FDA.reportPublic FDA data

20GA Soft Tip Aspirating Laser Probe - Iridex

Primary DI
10632307000291
Brand
20GA Soft Tip Aspirating Laser Probe - Iridex
Company
PEREGRINE SURGICAL, LTD.
Model
PD720.62
Device description
20GA Soft Tip Aspirating Laser Probe - Iridex
Published
2016-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQEINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061024000PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60Peregrine Surgical , Ltd.2006-06-21HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307000291PackageGS15In Commercial Distribution
00632307000294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700029110632307000291
00632307000294006323070002946323070002940632307000294

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 Gauge20Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
622467348
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1063230700229523GA Soft Tip Cannula - 1mm Silicone1272.SD123-002023-05-10
1063230700230125GA Soft Tip Cannula - 1mm Silicone1272.SD125-002023-05-10
1063230700231825GA Flexible 41GA Cannula1270.05-002023-05-10
1063230700146520GA Soft Tip CannulaPD220.002016-05-06
1063230700147220GA Flexible 41GA CannulaPD220.412016-05-06
1063230700148923GA Soft Tip CannulaPD223.002016-05-06
1063230700149623GA Soft Tip Cannula - 1mm SiliconePD223.012016-05-06
1063230700150223GA Flexible 41GA CannulaPD223.412016-05-06
1063230700151925GA Soft Tip CannulaPD225.002016-05-06
1063230700152625GA Soft Tip Cannula - 1mm SiliconePD225.012016-05-06
1063230700153325GA Flexible 41GA CannulaPD225.412016-05-06
10632307002202DMEK/DSAEK Infusion SleevePD500.272018-02-01
10632307002226DMEK Infusion SleevePD500.272018-05-15
10632307002240DMEK/DSAEK Infusion SleevePD500.272018-10-18
1063230700019220GA End Irrigating Light Pipe - 297 ConnectorPD102.022016-05-06
1063230700024623GA Light Pipe - GrieshaberPD103.232016-05-06
1063230700033823GA Straight Pick - AlconPD123.03A2016-05-06
1063230700087123GA Light Pipe - AlconPD102.232016-05-06
1063230700095620GA Light PipePD100.002016-05-06
1063230700096320GA Side Irrigating Light PipePD100.012016-05-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
00380650003294UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003300UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003317UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003614UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003621UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003638UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003669UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003676UNITYAlcon Laboratories, Inc.HQE2025-04-08
0871787203654027G Two Dimensional Cutter – 20k CPMD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-04-01
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
00380650003324UNITYAlcon Laboratories, Inc.HQE2024-11-19
00380650003348UNITYAlcon Laboratories, Inc.HQE2024-11-19
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-09-27
00380650001252UNITYAlcon Laboratories, Inc.HQE2024-07-02
08717872035109EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035116EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035123EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035307EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
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08717872035321EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
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