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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Corneal marker, single-use FDA UDI
Device Name
Wallace Mendez Titanium Degree Gauge, FDA UDI
Model / Reference
S34547.100T FDA UDI
Description
Wallace Mendez Titanium Degree Gauge, FDA UDI

Identifiers

Catalog Number
S34547.100T FDA UDI
Primary DI / UDI-DI
B382S34547100T0 FDA UDI
FDA Product Code
HMR FDA UDI
GMDN Term
Corneal marker, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Corneal marker, single-use

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corneal marker, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI 4adc7bcd-a12a-4515-9cb2-c0a6bb4f82f0 35 fields · synced May 31, 2026