FDA.reportPublic FDA data

N.A.

Primary DI
04049368128113
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
32960
Catalog number
32960
Device description
N.A.
Published
2021-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NCEInjector, capsular tension ring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCEInjector, Capsular Tension RingOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001125000GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGGeuder GmbH2000-10-04NCE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368128113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368128113040493681281134049368128113

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, reusableA hand-held, manual, ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of lightweight metal materials [e.g., titanium (Ti)], has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316267202
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055313811398Duckworth & KentDUCKWORTH AND KENT LIMITEDNCE2022-08-31
04049368128083N.A.Geuder AktiengesellschaftNCE2021-02-23
04049368128182N.A.Geuder AktiengesellschaftNCE2021-02-23