FDA.report

Fisherbrand

Primary DI
20613647011977
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
IJL-6115-PS-600621
Catalog number
12550115
Device description
INKJT SLD PLS BRT ORNG 1440/CS
Published
2022-12-07
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
true

Related Records

Contact Domains

Product Codes

CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20613647011977PackageGS11In Commercial Distribution
00613647011973PrimaryGS10
10613647011970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364701197720613647011977
00613647011973006136470119736136470119730613647011973
1061364701197010613647011970

GMDN Terms

TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags

DUNS number
004321519
Device count
1440
DM exempt
true
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
false

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30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

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