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Assembly Required Distributors

FDA UDI

Class I (US FDA UDI)

by Assembly Required Distributors Inc

Identity

Trade Name
Assembly Required Distributors FDA UDI
Generic Name
Chair/stool armrest FDA UDI
Device Name
Fixed height MRI stool - 18" seat hgt w/rubber tips - stackable FDA UDI
Model / Reference
CHM8058-01 FDA UDI
Description
Fixed height MRI stool - 18" seat hgt w/rubber tips - stackable FDA UDI

Identifiers

Primary DI / UDI-DI
00854362008767 FDA UDI
FDA Product Code
FZM FDA UDI
GMDN Term
Chair/stool armrest FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Chair/stool armrest

Assembly Required Distributors by Assembly Required Distributors Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chair/stool armrest.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Assembly Required Distributors Inc

Sources (1)

  • FDA UDI 3ea66e62-cdaf-444c-afed-dccdc776a980 33 fields · synced May 30, 2026