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, LG FDA UDI
Model / Reference: 101816 FDA UDI
Description: Cover, Back Table, LG FDA UDI

Identifiers

Catalog Number: 101816C FDA UDI
Primary DI / UDI-DI: 00812564030184 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 2.2 Pound FDA UDI
Width — 10 Inch FDA UDI
Height — 2 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.

ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Lac-Mac — Lac Mac, Ltd. · Class II
ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
Encompass — Encompass Group, L.L.C. · Class II
Fenestrated Heart Drape — STANDARD TEXTILE CO., INC. · Class II
ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Novo Health Services, Llc

Sources (1)

FDA UDI 552bd1be-beaf-4725-8287-2eafb729940d 37 fields · synced Jun 8, 2026