FDA.reportPublic FDA data

20GA Straight Laser Probe, SMA905

Primary DI
10632307002028
Brand
20GA Straight Laser Probe, SMA905
Company
PEREGRINE SURGICAL, LTD.
Model
GA-0042170
Device description
20GA Straight Laser Probe, SMA905
Published
2016-09-01
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
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024061000PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00Peregrine Surgical , Ltd.2003-03-07GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10632307002028PackageGS110In Commercial Distribution
00632307002021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063230700202810632307002028
00632307002021006323070020216323070020210632307002021

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)348-0456ryan@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
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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