FDA.reportPublic FDA data

N/A

Primary DI
00850003089218
Brand
N/A
Company
Optalmed, LLC
Model
7001
Catalog number
7001
Device description
Disposable Iris Retractors, 1 set of 5 retractors
Published
2021-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850003089003PrimaryGS10
00850003089034PrimaryGS10
00850003089171PrimaryGS10
00850003089188PrimaryGS10
00850003089218Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003089003008500030890038500030890030850003089003
00850003089034008500030890348500030890340850003089034
00850003089171008500030891718500030891710850003089171
00850003089188008500030891888500030891880850003089188
00850003089218008500030892188500030892180850003089218

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Caution
Special Storage Condition, Specify00Keep away from direct sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037077801
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003089362N/A703170312025-07-07
10850003089208N/A30-134-630-134-62021-03-10
10850003089086N/ARx5067B-5Rx5067B-52021-02-08
10850003089017N/A700270022021-02-01
00850003089225N/A700470042021-02-01
10850003089055N/A701370132021-02-01

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
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
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