← Back to catalogue

GuidedSMILE

FDA UDI

Class I (US FDA UDI)

by Guided Smile

Identity

Trade Name
GuidedSMILE FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
GuidedSMILE Surgical Guide FDA UDI
Model / Reference
NBGS FDA UDI
Description
GuidedSMILE Surgical Guide FDA UDI

Identifiers

Primary DI / UDI-DI
00850065193090 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Custom-made organ/bone anatomy model/surgical guide kit

GuidedSMILE by Guided Smile — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model/surgical guide kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Guided Smile

Sources (1)

  • FDA UDI 04f9553e-4f00-4b44-81c5-cd80056e73bb 33 fields · synced May 30, 2026