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NOVO Health Services, LLC

FDA UDI

Class I (US FDA UDI)

by Novo Health Services, Llc

Identity

Trade Name
NOVO Health Services, LLC FDA UDI
Generic Name
Surgical gown, reusable FDA UDI
Device Name
L4 PREMIUM GOWN, LG W/TWL FDA UDI
Model / Reference
613000 FDA UDI
Description
L4 PREMIUM GOWN, LG W/TWL FDA UDI

Identifiers

Catalog Number
613000 FDA UDI
Primary DI / UDI-DI
00812564038319 FDA UDI
510(k) Number
K982694 FDA UDI
FDA Product Code
FRL FDA UDI
FYA FDA UDI
GMDN Term
Surgical gown, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5300 FDA UDI
878.4040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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 — 1.1 Pound FDA UDI
Width — 7 Inch FDA UDI
Height — 3 Inch FDA UDI

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

Cleared under the same submission

K982694 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 113b65cf-39a9-4629-a3b0-da7302c1f4f4 38 fields · synced May 31, 2026