QuickDraw

FDA UDI

Class I (US FDA UDI)

by Paradigm Biodevices, Inc.

Identity

Trade Name: QuickDraw FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: QuickDraw Bone Harvester, 10mm FDA UDI
Model / Reference: 988-1000 FDA UDI
Description: QuickDraw Bone Harvester, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00850008316029 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone trephine, 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

Yes

FDA UDI

Single Use

Yes

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

Yes

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

Dimensions & Sizes

Size: Length — 230 Millimeter FDA UDI
Width — 10 Millimeter FDA UDI

Category: Bone trephine, reusable

QuickDraw by Paradigm Biodevices, Inc. — 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: Paradigm Biodevices, Inc.

Sources (1)

FDA UDI 67ac81d8-8c5a-47db-a630-12e53471face 35 fields · synced May 30, 2026