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Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical FDA UDI
Generic Name
Subcutaneous tunneller, reusable FDA UDI
Device Name
rumel tourniquet & obturator, obturator only, child, 8 1/4" (21.0 cm) FDA UDI
Model / Reference
C6665-00 FDA UDI
Description
rumel tourniquet & obturator, obturator only, child, 8 1/4" (21.0 cm) FDA UDI

Identifiers

Catalog Number
C6665-00 FDA UDI
Primary DI / UDI-DI
G586C6665000 FDA UDI
FDA Product Code
GAX FDA UDI
GMDN Term
Subcutaneous tunneller, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.5900 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Subcutaneous tunneller, reusable

Novo Surgical by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous tunneller, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI 46db5b3d-c53d-4681-bae6-05e5a7235e11 35 fields · synced May 29, 2026