Dci

FDA UDI

Class I (US FDA UDI)

by DCI International, LLC

Identity

Trade Name: DCI FDA UDI
Generic Name: Mouth gag, non-adjustable FDA UDI
Device Name: Mouth Props, Large Adult; Not Made w/Natural Rubber Latex, Box of 2 FDA UDI
Model / Reference: 2436 FDA UDI
Description: Mouth Props, Large Adult; Not Made w/Natural Rubber Latex, Box of 2 FDA UDI

Identifiers

Catalog Number: 2436 FDA UDI
Primary DI / UDI-DI: 10810021435074 FDA UDI
FDA Product Code: EIF FDA UDI
GMDN Term: Mouth gag, non-adjustable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

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

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: Mouth gag, non-adjustable

Dci by DCI International, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mouth gag, non-adjustable.

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Plasdent — PLASDENT CORP. · Class I
Plasdent — PLASDENT CORP. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
MOUTH PROP ADULT BITE BLOCK WITHOUT ATTACHMENT BEAUDRY STYLE — W.H. Holden, Inc. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I

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: DCI International, LLC

Sources (1)

FDA UDI 4f5d86ea-bbaa-441b-8eee-4d0281e18967 35 fields · synced Jun 9, 2026