FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613041533
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
11-4-5061
Device description
Keuch Small Pupil Dilatator, Guard Shaft, Diameter 6mm Shaft, Diameter 0.7mm, For Enlarging The Pupil, Overall Length 5" (129mm)
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HOCClip, iris retractor

Product Code Classifications

CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613041533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613041533001946130415331946130415330194613041533

GMDN Terms

TermDefinition
Intraocular retractor, reusableA 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 small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags

DUNS number
556623486
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01
00194613000011MSI Precision Specialty InstrumentsCA10102025-08-01
00194613000028MSI Precision Specialty InstrumentsCA10202025-08-01
00194613000059MSI Precision Specialty InstrumentsCA10502025-08-01
00194613000080MSI Precision Specialty InstrumentsCA10702025-08-01
00194613000097MSI Precision Specialty InstrumentsCA10802025-08-01
00194613000264MSI Precision Specialty InstrumentsCA12PK-302025-08-01
00194613000332MSI Precision Specialty InstrumentsCA19102025-08-01
00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
00194613000462MSI Precision Specialty InstrumentsCA20402025-08-01
00194613000509MSI Precision Specialty InstrumentsCA20802025-08-01
00194613000639MSI Precision Specialty InstrumentsCA22102025-08-01
00194613000707MSI Precision Specialty InstrumentsCA22802025-08-01
00194613000769MSI Precision Specialty InstrumentsCA23402025-08-01
00194613000806MSI Precision Specialty InstrumentsCA23702025-08-01
00194613000813MSI Precision Specialty InstrumentsCA23802025-08-01
00194613000912MSI Precision Specialty InstrumentsCA24702025-08-01
00194613000943MSI Precision Specialty InstrumentsCA25002025-08-01
00194613000950MSI Precision Specialty InstrumentsCA2500-1.5-902025-08-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00194613103095MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
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
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
10845819005207Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
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
00813059018397Diamatrix LtdDiamatrixHOC2022-10-31
00840319726105Hayden MedicalHayden Medical, Inc.HOC2022-08-16
00886158007036Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007043Visitec® I-Ring®Beaver-Visitec International, Inc.HOC2022-01-20
10850003089208N/AOptalmed, LLCHOC2021-03-10
10850003089086N/AOptalmed, LLCHOC2021-02-08
00850003089218N/AOptalmed, LLCHOC2021-02-01
10850003089017N/AOptalmed, LLCHOC2021-02-01
00850003089225N/AOptalmed, LLCHOC2021-02-01
10850003089055N/AOptalmed, LLCHOC2021-02-01
18717872009640Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HOC2021-01-07
18717872009657Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HOC2021-01-07
00810799031990Stephens InstrumentsKRISHNA IMPORTS INCHOC2020-09-22
00841668103685Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103692Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103708Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103715Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103722Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14