DEVICE: Tissue-Tek® Accu-Edge® (00615233079152)

Device Identifier (DI) Information

Tissue-Tek® Accu-Edge®
4848
In Commercial Distribution
4848
SAKURA FINETEK U.S.A., INC.
00615233079152
GS1

1
179135769 *Terms of Use
Grossing Wells, Left-handed
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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?
59750 Analogue durometer
A hand-held, mechanical instrument intended to measure the hardness of a material (e.g., skin, elastomers, natural rubbers, neoprenes, casting resins). It typically consists of a needle gauge (indentor) at the distal end, which is intended to be pressed onto the surface of the specimen, and an analogue display. Hardness may be measured on a number of durometer scales, depending on intended use of the material; this device is typically designed to provide a measurement on a specific durometer scale. This is a reusable device.
Active false
32873 Surgical tamp, reusable
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Active false
58387 Surgical cutting/shaping board, reusable
A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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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

11d219d3-f3a6-48bf-b324-17904c1da19d
November 09, 2022
3
March 31, 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

[?]
No
No
No
No
No CLOSE

Customer Contact

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