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.
4848
In Commercial Distribution
4848
SAKURA FINETEK U.S.A., INC.
Grossing Wells, Left-handed
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
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 |
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No Device Sizes |
Device Record Status
11d219d3-f3a6-48bf-b324-17904c1da19d
November 09, 2022
3
March 31, 2020
November 09, 2022
3
March 31, 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