FDA.report

Tissue-Tek® Lab Aid®

Primary DI
08720177655637
Brand
Tissue-Tek® Lab Aid®
Company
SAKURA FINETEK U.S.A., INC.
Model
4014
Catalog number
4014
Device description
Drawer Section 14 x 25 x 76 mm, Green
Published
2020-06-20
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
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08720177655637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08720177655637087201776556378720177655637

GMDN Terms

TermDefinition
Microscope slide cabinetA furniture-like device designed for the secure storage of many prepared laboratory specimen slides, e.g., histology microscope slides. The slides will typically be placed in dedicated trays. This device may be used, e.g., in the laboratory or a physician's office and can be locked to prevent access by an unauthorized person.

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
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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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
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