FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNLProbe, lachrymal

Product Code Classifications

CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049368130000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049368130000040493681300004049368130000

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316267202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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