FDA.reportPublic FDA data

N.A.

Primary DI
04049368141181
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
36312
Catalog number
36312
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
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368141181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368141181040493681411814049368141181

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, reusableA hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

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
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
04049368172628N.A.42341423412021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123779Waever Chalazion ForcepsSONTEC INSTRUMENTS, INC.HNR2026-09-18
00192896123786Prince Trachoma Eye ForcepsSONTEC INSTRUMENTS, INC.HNR2026-09-18
14546951639997MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640009MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640016MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640023MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640030MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640047MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640054MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640061MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640078MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640085MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640092MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640108MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640115MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640122MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
04059453116635Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNR2026-08-25
00190776426576MillenniumAvalign Technologies, Inc.HNR2026-08-19
00190776426774MillenniumAvalign Technologies, Inc.HNR2026-08-19
00198506093975ELMED INCORPORATEDELMED INCORPORATEDHNR2026-08-18
G346EA41HSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-08-14
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27