AccessGUDID - DEVICE: Tissue-Tek® Accu-Edge® (14902470068852)

GUDID

Device Identifier (DI) Information

Brand Name: Tissue-Tek® Accu-Edge®
Version or Model: 4783
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4783
Company Name: SAKURA FINETEK U.S.A., INC.

Primary DI Number: 14902470068852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179135769 *Terms of Use

Device Description: Autopsy Blade, 170 mm; 5/case

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37826	Autopsy knife	A hand-held manual surgical instrument with a handle and a heavy single-edged blade, of various shapes and sizes, used during an autopsy to cut open and dissect a cadaver. It is typically a one-piece instrument made of high-grade stainless steel; it may employ synthetic or wood material as part of the handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOK	SCISSORS, MEDICAL, DISPOSABLE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1249dc9e-1514-477e-b159-30ff54e8ff3b
Public Version Date: April 08, 2020
Public Version Number: 1
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(310)972-7800
Email: TS@sakuraus.com

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