Fisherbrand

Basic Information

• Brand Name: Fisherbrand
• Primary DI: 00613647028346
• Version / Model: 11002204
• Catalog Number: 11002204
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Labeler DUNS: 004321519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 1
• Public Version Date: 2025-07-08
• Public Version Status: New
• Public Device Record Key: 791c8278-dd6f-4d3c-ab7d-f70e3ee6fd53

Device Description

PROTOCOL DECALCIFYN SOL B 32OZ

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDX	SOLUTION, DECALCIFIER, ACID CONTAINING	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57785	Decalcifying solution IVD	A solution intended to be used as a decalcifying agent in the processing of clinical specimens and biological tissues for subsequent in vitro diagnostic analysis. It is typically in the form of an inorganic acid [e.g., hydrochloric acid (HCl)], organic acid [e.g., formic acid (CH2O2)] or a chelating agent [e.g., ethylenediaminetetraacetic acid (EDTA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613647028340	GS1	CASE	1	In Commercial Distribution
Primary	00613647028346	GS1
Unit of Use	10613647028343	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]