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Special Plus model gown (length 109 cm ) size S

FDA UDI

Class I (US FDA UDI)

by Omnia Spa

Identity

Trade Name
Special Plus model gown (length 109 cm ) size S FDA UDI
Generic Name
Surgical gown, single-use FDA UDI
Device Name
Special Plus model gown (length 109 cm ) size S FDA UDI
Model / Reference
30.D2170.00 FDA UDI
Description
Special Plus model gown (length 109 cm ) size S FDA UDI

Identifiers

Primary DI / UDI-DI
08056646507436 FDA UDI
FDA Product Code
OEA FDA UDI
GMDN Term
Surgical gown, single-use 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

Yes

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

Yes

FDA UDI

Category: Surgical gown, single-use

Special Plus model gown (length 109 cm ) size S by Omnia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical gown, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omnia Spa

Sources (1)

  • FDA UDI fc87a082-d49a-4e38-bbc8-7cfa1cdf8410 33 fields · synced May 30, 2026