FDA.report

N.A.

Primary DI
04049368055426
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
150402
Catalog number
150402
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
04049368055426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049368055426040493680554264049368055426

GMDN Terms

TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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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04049368061847N.A.16106161062021-07-05

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