Alm Set

FDA UDI

Class I (US FDA UDI)

by H.s. Hospital Service Spa

Identity

Trade Name: ALM SET FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Device Name: ALM SET 20GX150MM FDA UDI
Model / Reference: ALM SET V TYPE FDA UDI
Description: ALM SET 20GX150MM FDA UDI

Identifiers

Catalog Number: ALM 2015 FDA UDI
Primary DI / UDI-DI: 08033003340127 FDA UDI
FDA Product Code: MIJ FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 150 Millimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI

Category: Radiological image marker, implantable

Alm Set by H.s. Hospital Service Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: H.s. Hospital Service Spa

Sources (1)

FDA UDI e3ede4fa-4b08-4526-8107-594a314d9686 36 fields · synced May 30, 2026