FDA.reportPublic FDA data

MST/Packard .7mm straight PT Dwy 30°

Primary DI
00084468500784
Brand
MST/Packard .7mm straight PT Dwy 30°
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
PT-32430-1
Catalog number
PT-32430-1
Device description
MST/Packard .7mm straight PT Dwy 30° Single Use
Published
2018-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943672000PHACO NEEDLES AND TIPSMicrosurgical Technology, Inc.1994-10-13HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084468500784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084468500784000844685007840844685007840084468500784

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification system handpiece tip, reusableA device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a reusable device.

Sterilization Methods#

Method table
Method
Radiation Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
097824130
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00844685001279Duet Forceps HandleDFH-0007DFH-00072018-09-18
00844685001408MST 360° Forceps HandleDFH-0021DFH-00212018-09-18
00844685001460MST Touch Forceps HandleDFH-0028DFH-00282018-09-18
00844685005536Handle Assy, Single-Use, PackagedDFH-1028DFH-10282018-09-18
00844685014309ArcDuo, Guarded Depth Paired Ophthalmic Knife 10mmARC-00012025-10-10
00844685014316ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mmARC-00022025-10-10
108446850055401X, 25g Ahmed Micro-GraspersAMG-1001AMG-10012018-09-18
108446850055641X 23g MicroHolding ForcepsDFH-1019DFH-10192018-09-18
1084468500630125g 1X Ahmed Micro-Graspers lgr tpsDFH-1034DFH-10342018-09-18
00844685011124Accutome SurgicalAF41202023-03-14
00844685011131Accutome SurgicalAF4130 2023-03-14
0084468500123123g Ahmed Micro-Tying ForcepsDFH-0003DFH-00032018-09-18
00844685001248Ahmed Schlemm's Canal, Head, 23GaDFH-0004DFH-00042018-09-18
0084468500129323g Ahmed Micro-Graspers, Curved ShaftDFH-0009DFH-00092018-09-18
0084468500131623g Ahmed Micro-Graspers, Straight ShaftDFH-0011DFH-00112018-09-18
0084468500133023g MST Tissue Grasper ForcepsDFH-0014DFH-00142018-09-18
0084468500134723g Verisyse Enclavation ForcepsDFH-0015DFH-00152018-09-18
0084468500135423g Verisyse Lens Holding ForcepsDFH-0016DFH-00162018-09-18
00844685001361MST ICL Grasping ForcepsDFH-0017DFH-00172018-09-18
0084468500137823g MST Micro-Holding ForcepsDFH-0019DFH-00192018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQC2026-04-09
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07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
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08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
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08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
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