Sheen Cartilage Cutting Grid

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: SHEEN CARTILAGE CUTTING GRID FDA UDI
Generic Name: Surgical cutting/shaping board, reusable FDA UDI
Device Name: SHEEN CARTILAGE CUTTING GRID FDA UDI
Model / Reference: 350-846 FDA UDI
Description: SHEEN CARTILAGE CUTTING GRID FDA UDI

Identifiers

Catalog Number: 350-846 FDA UDI
Primary DI / UDI-DI: 00192896093836 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical cutting/shaping board, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 70 Millimeter FDA UDI
Width — 40 Millimeter FDA UDI
Height — 2 Millimeter FDA UDI

Category: Surgical cutting/shaping board, reusable

Sheen Cartilage Cutting Grid by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical cutting/shaping board, reusable.

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MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Preparation tray, stainless steel — Spiggle & Theis Medizintechnik GmbH · Class I
Gyrus ACMI — Gyrus Acmi, Inc. · Class I
V. Mueller — STERIS CORPORATION · 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: Sontec Instruments, Inc.

Sources (1)

FDA UDI f8986c85-9260-4782-bbc5-0ee11ffd4fcd 36 fields · synced Jun 8, 2026