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iSmile

FDA UDI

Class I (US FDA UDI)

by Ismile Dental Products Inc.

Identity

Trade Name
iSmile FDA UDI
Generic Name
Patient examination/treatment drape, single-use FDA UDI
Device Name
VP Patient Bib 2-Ply Paper + 1-Ply Poly 13" x 18" Blue FDA UDI
Model / Reference
25-4091 FDA UDI
Description
VP Patient Bib 2-Ply Paper + 1-Ply Poly 13" x 18" Blue FDA UDI

Identifiers

Catalog Number
25-4091 FDA UDI
Primary DI / UDI-DI
00816419020115 FDA UDI
FDA Product Code
KHR FDA UDI
GMDN Term
Patient examination/treatment drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6050 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient examination/treatment drape, single-use

iSmile by Ismile Dental Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient examination/treatment drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ismile Dental Products Inc.

Sources (1)

  • FDA UDI c81da0d9-45b0-4f4b-a8d8-244c55e3e21e 35 fields · synced May 30, 2026