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Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical Inc. FDA UDI
Generic Name
Self-retaining surgical retractor, single-use FDA UDI
Device Name
paparella-weitlaner retractor, 3.3 cm inside spread, 2x2 semi-sharp teeth, self-retaining prongs, 13.0 mm long, 5" (12.5 cm) FDA UDI
Model / Reference
E7217-15 FDA UDI
Description
paparella-weitlaner retractor, 3.3 cm inside spread, 2x2 semi-sharp teeth, self-retaining prongs, 13.0 mm long, 5" (12.5 cm) FDA UDI

Identifiers

Catalog Number
E7217-15 FDA UDI
Primary DI / UDI-DI
00842331161834 FDA UDI
FDA Product Code
KAL FDA UDI
GMDN Term
Self-retaining surgical retractor, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Self-retaining surgical retractor, single-use

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

Similar devices

Also classified as Self-retaining surgical retractor, single-use.

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 7b48994d-5289-40b9-a997-ceb381b8bf92 35 fields · synced May 30, 2026