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Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED INCORPORATED FDA UDI
Generic Name
Open-surgery stone-retrieval forceps FDA UDI
Device Name
3 Fr. (1.0 mm), 70cm, Flexible “Dormia” Stone Dislodger, 20mm basket length, 4 basket type wires FDA UDI
Model / Reference
31370-05 FDA UDI
Description
3 Fr. (1.0 mm), 70cm, Flexible “Dormia” Stone Dislodger, 20mm basket length, 4 basket type wires FDA UDI

Identifiers

Catalog Number
31370-05 FDA UDI
Primary DI / UDI-DI
00842180149120 FDA UDI
FDA Product Code
KOA FDA UDI
GMDN Term
Open-surgery stone-retrieval forceps FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 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: Open-surgery stone-retrieval forceps

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

Similar devices

Also classified as Open-surgery stone-retrieval forceps.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 84738519-e225-4259-a2a4-80dde390223f 35 fields · synced Jun 6, 2026