FDA.reportPublic FDA data

MST .8mm Straight Phaco Tip 15 Deg

Primary DI
00844685000579
Brand
MST .8mm Straight Phaco Tip 15 Deg
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
PT-28115-1
Catalog number
PT-28115-1
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
00844685000579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685000579008446850005798446850005790844685000579

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""]"
Radiation Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
097824130
Device count
1
Lot or batch
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
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
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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
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
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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