FDA.report

Microscope Slides

Primary DI
00616784417134
Brand
Microscope Slides
Company
DYNAREX CORPORATION
Model
4171
Device description
Microscope Slides, Frosted, Corner Grounded, 3"x1"x1mm
Published
2021-09-01
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
KEWSlides, Microscope

Product Code Classifications

CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784417134PackageGS120In Commercial Distribution
00616784417127PrimaryGS10
00616784417110Unit of UseGS10
00810180840613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784417134006167844171346167844171340616784417134
00616784417127006167844171276167844171270616784417127
00616784417110006167844171106167844171100616784417110
00810180840613008101808406138101808406130810180840613

GMDN Terms

TermDefinition
Microscope slide coverslip IVDA thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
72
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
true
Sterilization required before use
false

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