AccessGUDID - DEVICE: Rowley Biochemical Neutral Buffered Formalin (SO334852042008)

GUDID

Device Identifier (DI) Information

Brand Name: Rowley Biochemical Neutral Buffered Formalin
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRANSENE COMPANY, INC.

Primary DI Number: SO334852042008
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044815983 *Terms of Use

Device Description: Neutral Buffered Formalin

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?
57757	10% Neutral buffered formalin IVD	A 10% neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IFP	Formalin, Neutral Buffered

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
Total Volume: 1 Gallon
Total Volume: 1 Quart
Total Volume: 1 Pint
Total Volume: 8 Fluid Ounce
Total Volume: 4 Fluid Ounce

Device Record Status

Public Device Record Key: ef6ed25e-ff4f-4b12-9bc6-099f88f6b134
Public Version Date: September 23, 2019
Public Version Number: 1
DI Record Publish Date: September 13, 2019