AccessGUDID - DEVICE: Fisherbrand (00613647023051)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 58670
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22047068
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647023051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2000
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: CASETTE TP IV BASE BLU 2000/CS

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: 9641ccca-cca9-434c-855f-ae3b1f7a64e8
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022