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restor3d Disposable Instrument, Wedge Trial

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Disposable Instrument, Wedge Trial FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Device Name
Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 08/10mm Thickness FDA UDI
Model / Reference
6101-NSP-C0810 FDA UDI
Description
Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 08/10mm Thickness FDA UDI

Identifiers

Primary DI / UDI-DI
00840097503226 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant/trial-implant/sizer holder, single-use

restor3d Disposable Instrument, Wedge Trial by Restor3D — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant/trial-implant/sizer holder, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI 232acd8a-ff9b-4305-8e37-400cb9810ee1 33 fields · synced May 30, 2026