Fisherbrand

FDA UDI

Class I (US FDA UDI)

by Fisher Scientific Company L.l.c.

Identity

Trade Name: Fisherbrand FDA UDI
Generic Name: Decalcifying solution IVD FDA UDI
Device Name: PROTOCOL DECALCIFYN SOL B 32OZ FDA UDI
Model / Reference: 11002204 FDA UDI
Description: PROTOCOL DECALCIFYN SOL B 32OZ FDA UDI

Identifiers

Catalog Number: 11002204 FDA UDI
Primary DI / UDI-DI: 00613647028346 FDA UDI
FDA Product Code: KDX FDA UDI
GMDN Term: Decalcifying solution IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Decalcifying solution IVD

Fisherbrand by Fisher Scientific Company L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Decalcifying solution IVD.

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I.E.D. Unit (Ion-Exchange Decal Unit) — BIOCARE MEDICAL, LLC · Class I
I.E.D. Unit (Ion-Exchange Decal Unit) — BIOCARE MEDICAL, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fisher Scientific Company L.l.c.

Sources (1)

FDA UDI 791c8278-dd6f-4d3c-ab7d-f70e3ee6fd53 35 fields · synced Jun 8, 2026