FDA.report

Fisherbrand

Primary DI
20613647021082
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
22048113
Catalog number
22048113
Device description
FB CASSETTE BPSY TAPD GRN M/CS
Published
2022-11-29
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
IDZCASSETTES, TISSUE

Product Code Classifications

CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20613647021082PackageGS11In Commercial Distribution
00613647021088PrimaryGS10
10613647021085Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702108220613647021082
00613647021088006136470210886136470210880613647021088
1061364702108510613647021085

GMDN Terms

TermDefinition
Histology tissue cassette lid IVDA device intended to be attached to and cover the top of a histology tissue cassette to prevent loss of a clinical tissue specimen (e.g., biopsy specimen) during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination or storage. It is typically made of stainless steel and includes drainage holes to allow infiltration of reagents during tissue processing. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
004321519
Device count
1000
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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