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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
Patient surgical drape, reusable FDA UDI
Device Name
Cover, Back Table M FDA UDI
Model / Reference
1822 FDA UDI
Description
Cover, Back Table M FDA UDI

Identifiers

Catalog Number
1822B FDA UDI
Primary DI / UDI-DI
00812564036292 FDA UDI
510(k) Number
K080796 FDA UDI
K982694 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Patient surgical drape, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Weight — 1.8 Pound FDA UDI
Width — 9 Inch FDA UDI
Height — 3 Inch FDA UDI

Category: Patient surgical drape, reusable

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

Similar devices

Also classified as Patient surgical drape, reusable.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ee7483f4-d296-48c1-9ada-4f330cf646fa 37 fields · synced May 30, 2026