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Wexler Surgical, Inc.

FDA UDI

Class I (US FDA UDI)

by Wexler Surgical, Inc.

Identity

Trade Name
Wexler Surgical, Inc. FDA UDI
Generic Name
Vascular dilator, reusable FDA UDI
Model / Reference
AL0926.1 FDA UDI

Identifiers

Primary DI / UDI-DI
M944AL092610 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Vascular dilator, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
Not 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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 80999227-b00f-4210-a0e1-8d5474d9f585 33 fields · synced Jun 9, 2026