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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
FLOSEAL NEEDLE, 15DG., BEND, FEMALE LUER LOCK, 4 1/2" OVERAL LENGTH, 3 1/2" WORKING LENGTH, 1/4" ENLARGED TIP FDA UDI
Model / Reference
ST182536 FDA UDI
Description
FLOSEAL NEEDLE, 15DG., BEND, FEMALE LUER LOCK, 4 1/2" OVERAL LENGTH, 3 1/2" WORKING LENGTH, 1/4" ENLARGED TIP FDA UDI

Identifiers

Catalog Number
ST182536 FDA UDI
Primary DI / UDI-DI
00842180192645 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT) 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT)

Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI aca8bd52-79a3-4139-a59c-dc2f25f97b10 35 fields · synced May 30, 2026