Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED INCORPORATED FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: ELMED CONTINUOUS FLOW OPERATING SHEATH, 7MM DIA., WITH INSTRUMENT CHANNEL; CONSISTING OF: (1) 51400-16A - 5FR EXAMINATION SHEATH, (1) 51400-16B 7MM OUTER SHEATH, (1) 51400-16C OBTURATOR FDA UDI
Model / Reference: 51400-16 FDA UDI
Description: ELMED CONTINUOUS FLOW OPERATING SHEATH, 7MM DIA., WITH INSTRUMENT CHANNEL; CONSISTING OF: (1) 51400-16A - 5FR EXAMINATION SHEATH, (1) 51400-16B 7MM OUTER SHEATH, (1) 51400-16C OBTURATOR FDA UDI

Identifiers

Catalog Number: 51400-16 FDA UDI
Primary DI / UDI-DI: 00198506084430 FDA UDI
FDA Product Code: KOA FDA UDI
GMDN Term: Endoscope sheath, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope sheath, reusable

Elmed Incorporated by Elmed Incorporated — 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: Elmed Incorporated

Sources (1)

FDA UDI 2dc18467-0021-4454-a652-325b93007981 35 fields · synced Jun 8, 2026