FDA.reportPublic FDA data

N.A.

Primary DI
04049368130000
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
33194
Catalog number
33194
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
HNLProbe, lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368130000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368130000040493681300004049368130000

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tube insertion hook/pusherA hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. It may be in the form of a cylinder for pushing the lacrimal tube downwards into the nasal cavity [post-osteotomy during canalicular bypass surgery, dacryocystorhinostomy (DCR)], or a pigtail hook probe that is inserted into the canaliculi through one lacrimal duct punctum and rotated for retrieval via the other punctum, leaving the attached lacrimal tube to be inserted in the canaliculi. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434397MillenniumAvalign Technologies, Inc.HNL2026-10-07
00198506090677ELMED INCORPORATEDELMED INCORPORATEDHNL2026-05-12
20757770455953Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00757770460670Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00190776410476MillenniumAvalign Technologies, Inc.HNL2025-09-11
00757770408818Bausch + LombBausch & Lomb IncorporatedHNL2025-08-14
00194613010690MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613010706MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613111731MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
04058935011819Bowman lachrymal probe, 0000-000Bausch & Lomb GmbHHNL2025-07-11
00840343726478GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726485GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726492GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726508GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726515GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726522GEN2SURGIX MEDICAL LLCHNL2025-06-16
G412PH19980MR PHACOCrestpoint Management LimitedHNL2025-06-09
G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19750MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197500MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH1975000MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197510MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197520MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197530MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197540MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19800MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19810MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19820MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19830MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19840MR PHACOCrestpoint Management LimitedHNL2025-06-07