AccessGUDID - DEVICE: Embedding Cassette (00810049682316)

GUDID

Device Identifier (DI) Information

Brand Name: Embedding Cassette
Version or Model: EC0611YXB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TYPENEX MEDICAL LLC

Primary DI Number: 00810049682316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 600850213 *Terms of Use

Device Description: Tissue, One Compartment, 5.0 x 1.0 mm, 30°, Lid Attached, Front Hinge, one piece, Yellow, Bulk

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:	Yes
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?
63791	Tissue embedding mould IVD, single-use	A plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDZ	Cassettes, Tissue

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: 703b5388-c993-4dc4-814f-2740311cceac
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022