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NOVO Health Services, LLC

FDA UDI

Class II (US FDA UDI)

by Novo Health Services, Llc

Identity

Trade Name
NOVO Health Services, LLC FDA UDI
Generic Name
Isolation gown, reusable FDA UDI
Device Name
PLR GOWNS, MED 24 PK N/S FDA UDI
Model / Reference
123744 FDA UDI
Description
PLR GOWNS, MED 24 PK N/S FDA UDI

Identifiers

Catalog Number
123744 FDA UDI
Primary DI / UDI-DI
00812564039477 FDA UDI
510(k) Number
K080707 FDA UDI
FDA Product Code
FYA FDA UDI
GMDN Term
Isolation gown, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 16.5 Pound FDA UDI
Width — 18 Inch FDA UDI
Height — 11 Inch FDA UDI

NOVO Health Services, LLC by Novo Health Services, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K080707 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Health Services, Llc

Sources (1)

  • FDA UDI 6ef89974-dc7e-41c2-bdff-792f16eaacc8 38 fields · synced May 31, 2026