FDA.reportPublic FDA data

Malyugin Ring System 7.0mm

Primary DI
00844685000043
Brand
Malyugin Ring System 7.0mm
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
MAL-0002-1
Catalog number
MAL-0002-1
Published
2018-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HOCClip, Iris Retractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844685000043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685000043008446850000438446850000430844685000043

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, single-useA sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
097824130
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00194613041533MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
00194613103095MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
08052276027054Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08052276027061Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
08058340220970Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08056477550502Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
04049368058045N.A.Geuder AktiengesellschaftHOC2023-07-06
04049368058199N.A.Geuder AktiengesellschaftHOC2023-07-06
00845819000458OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
00845819005200Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
10845819005207Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
00841668143452MAXIRIS FLEXIBLE IRIS RETRACTOR PACK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143469MAXIRIS AKAHOSHI FLAT IRIS RETRACT PK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143476MAXIRIS AKAHOSHI TW FIBR IRIS/CAP RETRACKATENA PRODUCTS, INC.HOC2022-12-13
00841668127377GRAETHER IRIS RETRACTOR STRAIGHTKATENA PRODUCTS, INC.HOC2022-12-07
00841668127384GRAETHER IRIS RETRACTOR ANGLEDKATENA PRODUCTS, INC.HOC2022-12-07
00841668118887Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668118894Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668119747Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00813059018403Diamatrix LtdDiamatrixHOC2022-10-31
00813059018397Diamatrix LtdDiamatrixHOC2022-10-31
00840319726105Hayden MedicalHayden Medical, Inc.HOC2022-08-16
30886158007037Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007036Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007043Visitec® I-Ring®Beaver-Visitec International, Inc.HOC2022-01-20
00850003089188N/AOptalmed, LLCHOC2021-03-10
00850003089201N/AOptalmed, LLCHOC2021-03-10
10850003089208N/AOptalmed, LLCHOC2021-03-10
00850003089034N/AOptalmed, LLCHOC2021-02-08