FDA.reportPublic FDA data

N.A.

Primary DI
04049368064695
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
17085
Catalog number
17085
Device description
N.A.
Published
2021-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNIRetractor, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368064695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368064695040493680646954049368064695

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, self-retainingA self-retaining, ophthalmic surgical instrument intended to be used to draw aside the margins of a periocular surgical wound, typically to access the nasolacrimal duct/lacrimal sac during an ophthalmic intervention; it is not intended to retract tissues of the eyeball and is not an eyelid speculum. The instrument is typically designed with two conjoined legs and a self-retaining mechanism, and is usually made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316267202
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368172512N.A.40008400082021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23

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