Watson Extraction System

FDA UDI

Class I (US FDA UDI)

by Simplex Designs, LLC

Identity

Trade Name: Watson Extraction System FDA UDI
Generic Name: Orthopaedic osteotome blade, single-use FDA UDI
Device Name: WATSON EXTRACTION SYSTEM FDA UDI
Model / Reference: 10001 FDA UDI
Description: WATSON EXTRACTION SYSTEM FDA UDI

Identifiers

Catalog Number: 10001 FDA UDI
Primary DI / UDI-DI: 00197169100013 FDA UDI
FDA Product Code: HWM FDA UDI
GMDN Term: Orthopaedic osteotome blade, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome blade, single-use

Watson Extraction System by Simplex Designs, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic osteotome blade, single-use.

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IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · Class I
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IMEDICOM HIGH SPEED BLADE — IMEDICOM CO., LTD. · 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: Simplex Designs, LLC

Sources (1)

FDA UDI bd4a0a33-6817-43d3-858e-14c359a165b7 34 fields · synced Jun 1, 2026