Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Mouth gag, adjustable, reusable FDA UDI
Device Name: dingman tongue blade, w/ groove, large, 30.0 mm x 68.0 mm FDA UDI
Model / Reference: E8319-24 FDA UDI
Description: dingman tongue blade, w/ groove, large, 30.0 mm x 68.0 mm FDA UDI

Identifiers

Catalog Number: E8319-24 FDA UDI
Primary DI / UDI-DI: G586E8319240 FDA UDI
FDA Product Code: KBN FDA UDI
GMDN Term: Mouth gag, adjustable, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Mouth gag, adjustable, reusable

Novo Surgical's Dingman Tongue Blade, with a groove and large dimensions (30.0 mm x 68.0 mm), is a reusable mechanical device used to maintain an open oral cavity during emergent placement of an artificial airway or for oral/dental surgical interventions. This innovative device has adjustable parts that can be placed between the upper and lower jaws of a patient, typically with support structures such as flat pivoted blades or two parallel plates moving apart with adjustments to a centre screw. It is available in various designs and has been certified by regulatory agencies.

Similar devices

Also classified as Mouth gag, adjustable, reusable.

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Ambler Surgical — Ambler Surgical, LLC · 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: Novo Surgical, Inc.

Sources (1)

FDA UDI 5d4e5802-47e4-48b4-99e2-bff786e9b5ed 35 fields · synced Oct 6, 2026