DEVICE: Tissue-Tek® Uni-Cassette® (00615233078186)

Device Identifier (DI) Information

Tissue-Tek® Uni-Cassette®
4171-02
In Commercial Distribution
4171-02
SAKURA FINETEK U.S.A., INC.
00615233078186
GS1

1
179135769 *Terms of Use
White, LWS, with one storage cabinet
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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?
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
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
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FDA Product Code

[?]
Product Code Product Code Name
KDT CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e693bf1b-c6d3-4e46-8b7f-e2571dee1062
November 03, 2023
5
January 22, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(310)972-7800
TS@sakuraus.com
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