FDA.report

Histo-Tek®

Primary DI
00615233083005
Brand
Histo-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
9358
Catalog number
9358
Device description
Biopsy with Lid Detached Yellow
Published
2020-01-25
Public version status
Update
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
00615233083005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233083005006152330830056152330830050615233083005

GMDN Terms

TermDefinition
Histological tissue cassette IVDA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a synthetic polymer container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags

DUNS number
179135769
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00615233011442Tissue-Tek Genie®8358-M2508358-M2502025-12-26
00615233013996Tissue-Tek Genie®8359-M2508359-M2502025-12-26
00615233014009Tissue-Tek Genie®8359-C0108359-C0102025-12-26
00615233014474Tissue-Tek Genie®8288-M2508288-M2502025-12-26
00615233014481Tissue-Tek Genie®8288-C0108288-C0102025-12-26
00615233014559Tissue-Tek Genie®8379-C0108379-C0102025-12-26
00615233014566Tissue-Tek Genie®8379-M2508379-M2502025-12-26
00615233011411Tissue-Tek Genie®8357-M2508357-M2502025-06-24
00615233011428Tissue-Tek Genie®8357-C0108357-C0102025-06-24
00615233013965Tissue-Tek Genie®8364-C0108364-C0102025-06-24
00615233013972Tissue-Tek Genie®8364-M2508364-M2502025-06-24
00615233011008Tissue-Tek Prisma®49002024-10-11
04946433600584Tissue-VIP® 6 AI60422024-10-11
00615233010605Tissue-Tek Genie®8386-C0108386-C0102024-05-17
00615233010612Tissue-Tek Genie®8386-M2508386-M2502024-05-17
00615233011312Tissue-Tek Genie®8337-M2508337-M2502024-05-17
00615233011350Tissue-Tek Genie®8356-C0108356-C0102024-05-17
00615233011367Tissue-Tek Genie®8356-M2508356-M2502024-05-17
00615233011329Tissue-Tek Genie®8337-C0108337-C0102024-05-10

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