FaceGuard™

FDA UDI

Class I (US FDA UDI)

by Dan Allen Surgical

Identity

Trade Name: FaceGuard™ FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501). FDA UDI
Model / Reference: 69200 FDA UDI
Description: FaceGuard Flat Frame - FaceGuard Universal Frame, width-adjustable. For use with FaceGuard Flat Tray (00811836030518) or Dual-Angle Tray (00811836030501). FDA UDI

Identifiers

Primary DI / UDI-DI: 00811836030525 FDA UDI
FDA Product Code: BWN FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4950 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Instrument tray, reusable

FaceGuard™ by Dan Allen Surgical — 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: Dan Allen Surgical

Sources (1)

FDA UDI 612b472e-b9a9-445a-be13-db9630a873c2 33 fields · synced Jun 8, 2026