Advansys®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: ADVANSYS® FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: The small left Dorsal Lisfranc trial plateis used in order to decide the appropriate size of the final plate to implant. The surgeon introduces the different sizes of trials until he finds the one that fits best. FDA UDI
Model / Reference: 169031ND FDA UDI
Description: The small left Dorsal Lisfranc trial plateis used in order to decide the appropriate size of the final plate to implant. The surgeon introduces the different sizes of trials until he finds the one that fits best. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780051657 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

Advansys® by Newdeal Sas — 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: Newdeal Sas

Sources (1)

FDA UDI 3e2b6e54-af08-43ff-94c4-683e31a47edc 36 fields · synced Jun 6, 2026