FDA.reportPublic FDA data

Alcon Grieshaber

Primary DI
07612717012226
Brand
Alcon Grieshaber
Company
Alcon Laboratories, Inc.
Model
611.74
Device description
Flexible Iris Retractors, 1 unit at 5 Hooks
Published
2020-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
07612717012226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612717012226076127170122267612717012226

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

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