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Elmed

FDA UDI

Class II (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Laparoscope system, reusable FDA UDI
Device Name
5MM DIA., 32CM REUSABLE MONOPOLAR NEEDLE ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH BARD/DAVOL DISPOSABLE SUCTION/IRRIGATION HANDLE FDA UDI
Model / Reference
52932-444 FDA UDI
Description
5MM DIA., 32CM REUSABLE MONOPOLAR NEEDLE ELECTRODE WITH PROTECTOR SLEEVE FOR USE WITH BARD/DAVOL DISPOSABLE SUCTION/IRRIGATION HANDLE FDA UDI

Identifiers

Catalog Number
52932-444 FDA UDI
Primary DI / UDI-DI
00842180111448 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscope system, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Laparoscope system, reusable

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

Similar devices

Also classified as Laparoscope system, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 9027fe67-3aa2-4f5a-ab43-ab83d9fe4b11 35 fields · synced Jun 6, 2026