AccessGUDID - DEVICE: Fisherbrand (00613647021033)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 22048106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22048106
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647021033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: FB CASSTTE P E TAPED PCH M/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?
66289	Histology tissue cassette lid IVD	A device intended to be attached to and cover the top of a histology tissue cassette to prevent loss of a clinical tissue specimen (e.g., biopsy specimen) during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination or storage. It is typically made of stainless steel and includes drainage holes to allow infiltration of reagents during tissue processing. This is a reusable 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: cb80b8cb-4f47-4ce1-a877-ccbd17a7ddfc
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022