FDA.report

Tissue-Tek VIP® 6

Primary DI
00615233080233
Brand
Tissue-Tek VIP® 6
Company
SAKURA FINETEK U.S.A., INC.
Model
6034
Catalog number
6034
Device description
Paraffin Scraper, Small
Published
2020-02-23
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

Contact Domains

Product Codes

CodeName
IEOPROCESSOR, TISSUE, AUTOMATED

Product Code Classifications

CodeDeviceSpecialtyClass
IEOProcessor, Tissue, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00615233080233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233080233006152330802336152330802330615233080233

GMDN Terms

TermDefinition
Cytology scraper, reusableA metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a reusable 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

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00615233010605Tissue-Tek Genie®8386-C0108386-C0102024-05-17
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00615233011312Tissue-Tek Genie®8337-M2508337-M2502024-05-17
00615233011350Tissue-Tek Genie®8356-C0108356-C0102024-05-17
00615233011367Tissue-Tek Genie®8356-M2508356-M2502024-05-17
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