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ShroudGuard™

FDA UDI

Class I (US FDA UDI)

by Dan Allen Surgical

Identity

Trade Name
ShroudGuard™ FDA UDI
Generic Name
Operating table pedestal protector FDA UDI
Device Name
ShroudGuard Surround HANA OR Table Pedestal Protector for Mizuho OSI® Hana® Orthopedic FDA UDI
Model / Reference
37350 FDA UDI
Description
ShroudGuard Surround HANA OR Table Pedestal Protector for Mizuho OSI® Hana® Orthopedic FDA UDI

Identifiers

Primary DI / UDI-DI
00811836030273 FDA UDI
FDA Product Code
BWN FDA UDI
GMDN Term
Operating table pedestal protector 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table pedestal protector

ShroudGuard™ by Dan Allen Surgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table pedestal protector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dan Allen Surgical

Sources (1)

  • FDA UDI 46f14339-6d07-4821-bd4a-54795ecb45b8 33 fields · synced May 30, 2026