FDA.reportPublic FDA data

Cyto-Tek®

Primary DI
00615233078438
Brand
Cyto-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4310
Catalog number
4310
Device description
Mailer
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233078438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233078438006152330784386152330784380615233078438

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags#

DUNS number
179135769
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615233000491Tissue-Tek Genie®8242-C0108242-C0102020-01-01
00615233000507Tissue-Tek Genie®8242-M2508242-M2502020-01-01
00615233000637Tissue-Tek Genie®8253-M2508253-M2502020-01-01
00615233000644Tissue-Tek Genie®8253-C0108253-C0102020-01-01
00615233011435Tissue-Tek Genie®8358-C0108358-C0102025-12-26
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
00615233010629Genemed®60-0226-1560-0226-152023-10-16
00615233003577Genemed®61-015461-01542023-07-05
00615233006066Genemed®60-0154-760-0154-72023-07-05
00615233008183Genemed®60-0221-1560-0221-152020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000061CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000085CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000092CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000108CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000115CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000122CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000139CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000146CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000153CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000160CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000177CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000184CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000191CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000207CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000214CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000221CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000238CRYO.SGreiner Bio - One GmbHKDT2022-12-06