restor3d Veritas rTSA Instrumentation

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d Veritas rTSA Instrumentation FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: 7.0 mm Drill Bit FDA UDI
Model / Reference: 6500-2070 FDA UDI
Description: 7.0 mm Drill Bit FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097515755 FDA UDI
510(k) Number: K243643 FDA UDI
FDA Product Code: KWS FDA UDI
PHX FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cannulated surgical drill bit, single-use

restor3d Veritas rTSA Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K243643 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Restor3D

Sources (1)

FDA UDI e421dabd-41c9-42d6-b602-71b23695985d 34 fields · synced Jun 8, 2026