AccessGUDID - DEVICE: Fisherbrand (00613647023778)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: 4585
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23730571
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647023778
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: FB OCT COMPOUND CLEAR 4OZ

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?
57739	Tissue freezing/embedding medium IVD	A tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEQ	MEDIA, MOUNTING, WATER SOLUBLE

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: e91aa1f3-5ed2-45ec-adc7-3a5bad7293fa
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022