DEVICE: Tissue-Tek® Uni-Cassette® (00615233078179)
Device Identifier (DI) Information
Tissue-Tek® Uni-Cassette®
4171-01
In Commercial Distribution
4171-01
SAKURA FINETEK U.S.A., INC.
4171-01
In Commercial Distribution
4171-01
SAKURA FINETEK U.S.A., INC.
White, with one storage cabinet
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62970 | Histology tissue cassette IVD, laboratory processing, single-use |
A 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 plastic 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. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.
|
Active | false |
35976 | Microscope slide cabinet |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KDT | CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5e55c611-4140-41f9-b3d2-83af970f883b
November 03, 2023
5
January 22, 2020
November 03, 2023
5
January 22, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(310)972-7800
TS@sakuraus.com
TS@sakuraus.com