FDA.report

N/A

Primary DI
00850003089362
Brand
N/A
Company
Optalmed, LLC
Model
7031
Catalog number
7031
Device description
Disposable Capsule Retractors, 1 set of 5 retractors
Published
2025-07-07
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

Related Records

Product Codes

CodeName
HNIRetractor, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850003089355PrimaryGS10
00850003089362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003089355008500030893558500030893550850003089355
00850003089362008500030893628500030893620850003089362

GMDN Terms

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

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 DIBrandModelCatalogPublished
10850003089208N/A30-134-630-134-62021-03-10
10850003089086N/ARx5067B-5Rx5067B-52021-02-08
00850003089218N/A700170012021-02-01
10850003089017N/A700270022021-02-01
00850003089225N/A700470042021-02-01
10850003089055N/A701370132021-02-01

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