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restor3d Disposable Instrument Kit

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Disposable Instrument Kit FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Device Name
Cervical Trial Kit with Stop, Medium Footprint, 5-10mm Height, 7 degree FDA UDI
Model / Reference
4110-S012 FDA UDI
Description
Cervical Trial Kit with Stop, Medium Footprint, 5-10mm Height, 7 degree FDA UDI

Identifiers

Primary DI / UDI-DI
00840097504865 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

Yes

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

Yes

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

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

restor3d Disposable Instrument Kit 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 9d76b481-352c-4ece-b8f8-7802e9b4ccc6 33 fields · synced Jun 1, 2026