CustomEyes®

FDA UDI

Class I (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name: CustomEyes® FDA UDI
Generic Name: Surgical/examination garment kit FDA UDI
Device Name: STANDARD PATIENT PACK 58000837 (60/SP) FDA UDI
Model / Reference: 58000837 FDA UDI
Description: STANDARD PATIENT PACK 58000837 (60/SP) FDA UDI

Identifiers

Catalog Number: 58000837 FDA UDI
Primary DI / UDI-DI: 30886158020623 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Surgical/examination garment kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Surgical/examination garment kit

CustomEyes® by Beaver-Visitec International, Inc. — 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: Beaver-Visitec International, Inc.

Sources (1)

FDA UDI 98e0e2c6-a158-45a5-b968-cc0c27ff8432 36 fields · synced Jun 1, 2026